1. Home
  2. Approved trials
  3. » فارسی

The effect of Low-dose Aspirin in the Prevention of Gastric Cancer

View the latest revision

History
# Registration date Revision Id
2 2020-06-02, 1399/03/13 251297
1 2017-04-21, 1396/02/01 1659
Changes made to previous revision

  • Help:

    Red color represents old content. It may be empty showing addition in the new version.
    Green color represents new content. It may be empty showing deletion in the new version.

    Inline Side by side
    Added new contents, deleted old contents, contents that are not changed.
    New table contents New table contents
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    Added new contents, contents that are not changed.
    Deleted old contents, contents that are not changed.
    Old table contents Old table contents
    Unchanged contents Unchanged contents
    New table contents New table contents
    Unchanged contents Unchanged contents

  • Protocol summary

    After determining inclusion and exclusion criteria, individuals will be tested for H pylori (HP) infection by urease breath test (UBT). H pylori-positive subjects will undergo eradication by standard protocol. After successful treatment, subjects will be randomly allocated in two groups; ASA and placebo. After giving informed consent, participants will be followed up for 10 years. During these 10 years, participants will be regularly contacted every year to determine outcomes and complications.
    empty
    افراد مورد مطالعه در ابتدا از نظر ابتلا به هلیکوباکتر پبلوری با استفاده از تست تنفسی بررسی خواهند شد. افراد مبتلا تحت درمان استاندارد دارویی قرار میگیرند. و بعد از منفی شدن ابتلا به به هلیکوباکتر پیلوری بصورت تصادفی به دو گروه تقسیم میشوند. به گروه اول قرص آسپیرین روزانه داده میشود و به گروه کنترل دارونما که توسط کارخانه سازنده آسپیرین تهیه شده داده میشود. افراد بعد از امضا فرم رضایت نامه وارد مطالعه شده و تا 10 سال پیگیری خواهند شد. این افراد سالانه از نظر عوارض دارویی و پیامد مطالعه پیگیری خواهند شد
    empty
    empty
    Evaluation of low-dose aspirin in the prevention of gastric cancer (GC)
    empty
    ارزیابی مصرف دوز پایین آسپرین در پیشگیری از سرطان معده
    empty
    Two arms parallel-group simple randomized clinical trial (phase 3,4) to assessment prevention of gastric cancer event. . The subjects (21000 persons) will first be tested for Helicobacter pylori using a stool antigen test. Affected people receive standard drug treatment. After being infected with Helicobacter pylori, they are randomly divided into two groups. The first group is given a daily aspirin tablet of 81 mg Parsdarou company and the control group is given a placebo prepared by the same factory. After signing the consent form, individuals will enter the study and will be followed up for 10 years.
    empty
    کارآزمایی بالینی فاز 3 و 4 دارای 'روه کنترل با گروهای موازی برای بررسی تاثیر پیشگیری از بروز سرطان معده .افراد مورد مطالعه (21000 نفر) در ابتدا از نظر ابتلا به هلیکوباکتر پبلوری با استفاده از تست آنتی ژن مدفوع بررسی خواهند شد. افراد مبتلا تحت درمان استاندارد دارویی قرار میگیرند. و بعد از منفی شدن ابتلا به به هلیکوباکتر پیلوری بصورت تصادفی ساده به دو گروه تقسیم میشوند. به گروه اول قرص آسپیرین mg 81 روزانه داده میشود و به گروه کنترل دارونما که توسط کارخانه پارس دارو سازنده آسپیرین تهیه شده داده میشود. افراد بعد از امضا فرم رضایت نامه وارد مطالعه شده و تا 10 سال پیگیری خواهند شد.
    empty
    Ardabil is an area with a high incidence of gastric cancer. In the University digestive disease research center, the group of people is randomly selected and invited using the city's household health record. After obtaining consent, individuals are evaluated for Helicobacter pylori and treated if necessary. They are then randomly divided into intervention and control groups and followed for ten years for gastric cancer. Participants and follow-up and statistics groups are blinded.
    empty
    اردبیل یک منطقه با بروز بالای سرطان معده است. در مرکز تحقیقات گوارش دانشگاه گروه افراد مورد نظر را با استفاده از پرونده بهداشتی خانوار شهر به طور تصادفی انتخاب و دعوت مینمایند. افراد پس از اخذ رضایتنامه مورد ارزیابی ابتلا به هلیکوباکتر قرار گرفته و در صورت لزون درمان میشوند. سپس در دو گروه مداخله و کنترل به طور تصادفی ساده تقسیم و به مدت ده سال از لحاظ بروز سرطان معده پیگیری میشوند.
    empty
    Inclusion Criteria: Without a history of gastric cancer Resident in Ardabil Age 35 - 70 Willing to undergo the treatments and procedures described in the protocol Willing to provide necessary biological specimens Willing to sign an informed consent form Exclusion Criteria: History of Severe dyspepsia, peptic ulcer, and GI bleeding/ perforation History of NSAID gastritis Known allergy to any of the study medications Known medical conditions that could limit life expectancy
    empty
    معیارهای ورود:  بدون سابقه سرطان معده  مقیم اردبیل  سن 35 - 70 سالگی  تمایل به انجام درمان ها و روش های توصیف شده در پروتکل  مایل به تهیه نمونه های بیولوژیکی لازم  مایل به امضای فرم رضایت آگاهانه معیارهای خروج:  سابقه سو dys هاضمه شدید ، زخم معده و خونریزی / سوراخ شدن دستگاه گوارش  سابقه گاستریت NSAID  آلرژی شناخته شده به هر یک از داروهای مورد مطالعه medical شرایط پزشکی شناخته شده که می تواند امید به زندگی را محدود کند
    empty
    Asprin and placebo group
    empty
    گروه آسپرین و گروه پلاسبو
    empty
    Gastric cancer event
    empty
    بروز سرطان معده

  • General information

    TELAPGC
    69
    70
    1
    1
    1
    1
    1
    2-3
    3
    28000
    21000
    2019-03-11, 1397/12/20
    2020-03-11, 1398/12/21
    empty
    The new sample size (21000 participants) was calculated and applied according to the updated information and executive restrictions.
    empty
    حجم نمونه جدید به تعداد 21000 نفر با توجه به اطلاعات به روز شده و محدودیتهای اجرایی محاسبه و اعمال گردید.
    Living in the province for ten years
    Negative pregnancy test
    Willing to participate in the study
    Willing to provide biological specimens
    Willing to sign an informed consent form
    سکونت در استان اردبیل برای ده سال
    تست حاملگی منفی
    تمایل به شرکت در مطالعه
    تمایل به دادن نمونه های مورد نظر
    امضا رضایت آگاهانه
    No history of Gastric cancer
    History of Severe dyspepsia, peptic ulcer and GI bleeding/ perforation
    History of NSAID gastritis
    Known allergy to any of the study medications
    Known medical conditions that could limit life expectancy (eg. HIV/AIDS, congestive heart failure, renal failure, hepatic failure, current or prior malignancy, any other chronic disease that limits function)
    Prior esophageal malignancy, gastric ulcer or a gastrectomy (full or partial)
    عدم ابتلا به سرطان معده
    سابقه سوء هاضمه شدید ، زخم معده و خونریزی / سوراخ شدن دستگاه گوارش
    سابقه گاستریت NSAID
    آلرژی شناخته شده به هر یک از داروهای مورد مطالعه
    شرایط پزشکی شناخته شده که می تواند امید به زندگی را محدود کند (به عنوان مثال HIV / AIDS ، نارسایی احتقانی قلب ، نارسایی کلیه ، نارسایی کبدی ، بدخیمی فعلی یا قبلی ، هر بیماری مزمن دیگری که عملکرد را محدود می کند)
    سابقه بدخیمی مری ، زخم معده یا گاسترکتومی (کامل یا جزئی)
    empty
    Eligible participants were randomly assigned to either aspirin or placebo groups with a 1:1 allocation ratio using permuted block randomization. Randomization was stratified by the initial HP status of subjects, baseline presence of intestinal metaplasia, and presence of two or more GC risk factors, to ensure recruitment balance between the two arms of the study. The permuted block sequence was generated with a block size of four. T
    empty
    شرکت‌کنندگان واجد شرایط به‌طور تصادفی به دو گروه آسپرین یا دارونما با نسبت تخصیص 1:1 با استفاده از تصادفی‌سازی بلوک‌های جایگزین تقسیم شدند. تصادفی‌سازی با وضعیت HP اولیه افراد، حضور پایه متاپلازی روده، و وجود دو یا چند عامل خطر GC طبقه‌بندی شد تا تعادل بین دو بازوی مطالعه تضمین شود. توالی بلوک جابجا شده با اندازه بلوک چهار توسط اکسل تولید شد.
    empty
    The provided medications, including aspirin and placebo, are small-sized white tablets. Aspirin and placebo bottles are both completely the same and labeled as “Artamed”. Both bottles contain 120 tablets, and the manufacturer prints a code on each bottle which can be used to determine the type of medication inside them. The codes were concealed in sealed and opaque envelopes with printed corresponding randomization numbers on them and kept safely in the study site with the personal investigator. DDRI provides and relabels the study drug and placebo to maintain the masking of the contents. The trial participants and care providers are blinded to the allocation. Staff independent of the study conduction enter data in the database using participants’ randomization codes so that outcome assessors and data analysts remain unaware of the treatment groups.
    empty
    داروهای ارائه شده، از جمله آسپرین و دارونما، قرص های سفید رنگ هستند. بطری های آسپرین و دارونما هر دو کاملاً یکسان هستند و برچسب "آرتامد" دارند. هر دو بطری حاوی 120 قرص هستند و سازنده روی هر بطری کدی را چاپ می کند که می تواند برای تعیین نوع داروی داخل آنها استفاده شود. کدها در پاکت های مهر و موم شده و مات با اعداد تصادفی چاپ شده مربوطه پنهان شده و به طور ایمن در محل مطالعه بانزدمحقق شخصی نگهداری می شدند. DDRI داروی مورد مطالعه و دارونما را برای حفظ پوشش محتویات فراهم می کند و مجدداً برچسب گذاری می کند. شرکت کنندگان در کارآزمایی و ارائه دهندگان مراقبت نسبت به تخصیص کور هستند.پرسنل مستقل از افراد انجام دهنده مطالعه، داده‌ها را با استفاده از کدهای تصادفی‌سازی شرکت‌کنندگان در پایگاه داده وارد می‌کنند تا ارزیابان پیامد و تحلیل‌گران داده از گروه‌های درمانی بی‌اطلاع بمانند.
    empty
    empty

  • Primary outcomes

    #1
    5 years following end of treatment
    visits at first, 12 weeks, every 4 months, 5 years and 10 years
    5 سال بعد از مصرف دارو
    ویزیت در ابتدا ، هفته 12 ، هر 4 ماه ، 5 سال و 10 سال
    Age standardized Incidence Rate
    Age standardized Incidence and Mortality Rate
    بروز استاندارد شده سنی
    بروز و مرگ و میر استاندارد شده سنی

  • Intervention groups

    #1
    Tablet Aspirin 81 mg once daily (Trial group)
    Tablet Aspirin 81 mg (oral) Parsdarou company once daily
    (قرص آسپیرین 81 میلیگرم روزانه (گروه کنترل
    قرص آسپیرین خوراکی 81 میلیگرم روزانه ساخت شرکت پارس دارو
    #2
    Treatment - Drugs
    Placebo
    Placebo (Control)
    Placebo (Control):Tablet placebo (oral) Parsdarou company once daily
    (دارو نما (گروه کنترل
    دارو نما (گروه کنترل):قرص پلاسبو روزانه ساخت شرکت پارس دارو

  • Recruitment centers

    #1
    Name of recruitment center - English: Ardabil Cohort Studies Center
    Name of recruitment center - Persian: مرکز مطالعات کوهورت اردبیل
    Full name of responsible person - English: Dr. Farhad Pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Street address - English:
    Street address - Persian:
    City - English: Ardabil
    City - Persian: اردبیل
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    Name of recruitment center - English: Ardabil Cohort Studies Center
    Name of recruitment center - Persian: مرکز مطالعات کوهورت اردبیل
    Full name of responsible person - English: Dr. Farhad Pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Street address - English: Digestive Disease Research Center, 30 Tir St. Ardabil
    Street address - Persian: مرکز تحقیقات بیماریهای گوارش، خیابان سی تیر، اردبیل
    City - English: اردبیل
    City - Persian: اردبیل
    Province: Ardabil
    Country: Iran (Islamic Republic of)
    Postal code: 5613658115
    Phone: +98 45 3325 9011
    Fax: +98 45 3326 2967
    Email: farhad.pourfarzi@gmail.com
    Web page address: https://research.arums.ac.ir/en/research-centers/ddrc/

  • Sponsors / Funding sources

    #1
    contact.organization_id:
    Name of organization / entity - English: Ministry of Health and Medical Education
    Name of organization / entity - Persian: وزارت بهداشت و درمان و آموزش پزشکی - معاونت تحقیقات و فن آوری
    Full name of responsible person - English: Dr. Reza Malekzadeh
    Full name of responsible person - Persian: دکتر رضا ملک زاده
    Street address - English: Ministry of Health and Medical Education
    Street address - Persian: وزارت بهداشت
    City - English: Tehran
    City - Persian: تهران
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ministry of Health and Medical Education
    Name of organization / entity - Persian: وزارت بهداشت و درمان و آموزش پزشکی - معاونت تحقیقات و فن آوری
    Full name of responsible person - English: Dr. Reza Malekzadeh
    Full name of responsible person - Persian: دکتر رضا ملک زاده
    Street address - English: Ministry of Health and Medical Education
    Street address - Persian: وزارت بهداشت
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1467664961
    Phone: +98 21 8145 5152
    Fax:
    Email: dr.reza.malekzadeh@gmail.com
    Web page address:
    empty
    50
    empty
    Public
    empty
    Domestic
    empty
    Academic
    #2
    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی اردبیل
    Full name of responsible person - English: Dr. Godrat Akhavan Akbari
    Full name of responsible person - Persian: دکتر قدرت اخوان اکبری
    Street address - English: Daneshgah St.
    Street address - Persian: خیابان دانشگاه
    City - English: Ardabil
    City - Persian: اردبیل
    Province:
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone:
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی اردبیل
    Full name of responsible person - English: Dr. Shahram Habibzadeh
    Full name of responsible person - Persian: دکتر شهرام حبیب زاده
    Street address - English: Daneshgah St.
    Street address - Persian: خیابان دانشگاه
    City - English: Ardabil
    City - Persian: اردبیل
    Province: Ardabil
    Country: Iran (Islamic Republic of)
    Postal code: 5618985991
    Phone: +98 45 3352 2100
    Fax:
    Email: s.habibzadeh@arums.ac.ir
    Web page address:
    empty
    10
    empty
    Public
    empty
    Domestic
    empty
    Academic
    #3
    contact.organization_id:
    Name of organization / entity - English: National Institute for Medical Research Development
    Name of organization / entity - Persian: مؤسسه ملی توسعه تحقیقات علوم پزشکی ایران
    Full name of responsible person - English: Dr. Reza Malekzadeh
    Full name of responsible person - Persian: دکتر رضا ملک زاده
    Street address - English: NIMAD, Besat St.
    Street address - Persian: خیابان بعثت
    City - English: Tehran
    City - Persian: تهران
    Province: Tehran
    Country: Iran (Islamic Republic of)
    Postal code: 1419693111
    Phone: +98 21 6690 0920
    Fax:
    Email: nimad@research.ac.ir
    Web page address: http://nimad.ac.ir/
    empty
    962245
    empty
    Yes
    empty
    40
    empty
    Public
    empty
    Domestic
    empty
    Academic
    empty
    National Institute for Medical Research Development
    empty
    مؤسسه ملی توسعه تحقیقات علوم پزشکی ایران

  • Person responsible for general inquiries

    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اردبیل
    Full name of responsible person - English: Dr. Farhad Pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Position - English: Principal Investigator/Associate Professor
    Position - Persian: محقق اصلی / دانشیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ardabil
    Street address - Persian: اردبیل
    City - English: Ardabil
    City - Persian: اردبیل
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 45 3325 9011
    Mobile: 00
    Fax:
    Email: f.pourfarzi@arums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اردبیل
    Full name of responsible person - English: Dr. Farhad Pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 29
    Area of specialty/work title - English: Cancer Epidemiology
    Area of specialty/work title - Persian: اپیدمیولوژی سرطانها
    Street address - English: Daneshgah St.
    Street address - Persian: خیابان دانشگاه
    City - English: Ardabil
    City - Persian: اردبیل
    Province: Ardabil
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5618985991
    Phone: +98 45 3325 9011
    Mobile: +98 914 151 1861
    Fax:
    Email: f.pourfarzi@arums.ac.ir
    Web page address:

  • Person responsible for scientific inquiries

    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی اردبیل
    Full name of responsible person - English: Dr. Farhad pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Position - English: Principal Investigator / Associate Professor
    Position - Persian: محقق و دانشیار
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Ardabil
    Street address - Persian: اردبیل
    City - English: Ardabil
    City - Persian: اردبیل
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: +98 45 3325 9011
    Mobile: 00
    Fax:
    Email: f.pourfarzi@arums.ac.ir
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی و خدمات بهداشتی و درمانی اردبیل
    Full name of responsible person - English: Dr. Farhad pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Position - English: Principal Investigator / Professor
    Position - Persian: محقق و استاد
    Latest degree: phd
    Area of specialty/work: 29
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Daneshgah St
    Street address - Persian: خیابان دانشگاه
    City - English: اردبیل
    City - Persian: اردبیل
    Province: Ardabil
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5618985991
    Phone: +98 45 3325 9011
    Mobile: +98 914 151 1861
    Fax:
    Email: farhad.pourfarzi@gmail.com
    Web page address:

  • Person responsible for updating data

    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اردبیل
    Full name of responsible person - English: Dr. Farhad Pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Position - English:
    Position - Persian:
    Latest degree:
    Area of specialty/work: 0
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English:
    Street address - Persian:
    City - English:
    City - Persian:
    Province:
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code:
    Phone: 00
    Mobile: 00
    Fax:
    Email:
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Ardabil University of Medical Sciences
    Name of organization / entity - Persian: دانشگاه علوم پزشکی اردبیل
    Full name of responsible person - English: Dr. Farhad Pourfarzi
    Full name of responsible person - Persian: دکتر فرهاد پورفرضی
    Position - English: Professor
    Position - Persian: استاد
    Latest degree: phd
    Area of specialty/work: 29
    Area of specialty/work title - English:
    Area of specialty/work title - Persian:
    Street address - English: Danshgah
    Street address - Persian: دانشگاه
    City - English: Ardabil
    City - Persian: اردبیل
    Province: Ardabil
    Province - English:
    Province - Persian:
    contact.provinces_available: 1
    Country: Iran (Islamic Republic of)
    Postal code: 5613658115
    Phone: +98 45 3325 9011
    Mobile: +98 914 151 1861
    Fax:
    Email: farhad.pourfarzi@gmail.com
    Web page address:

  • Sharing plan

    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    undecided
    empty
    no decision has been made for individual data publication by scientific committee
    empty
    هنوز برنامه برای انتشار توسط کمیته وجود ندارد

Protocol summary

Study aim
Evaluation of low-dose aspirin in the prevention of gastric cancer (GC)
Design
Two arms parallel-group simple randomized clinical trial (phase 3,4) to assessment prevention of gastric cancer event. . The subjects (21000 persons) will first be tested for Helicobacter pylori using a stool antigen test. Affected people receive standard drug treatment. After being infected with Helicobacter pylori, they are randomly divided into two groups. The first group is given a daily aspirin tablet of 81 mg Parsdarou company and the control group is given a placebo prepared by the same factory. After signing the consent form, individuals will enter the study and will be followed up for 10 years.
Settings and conduct
Ardabil is an area with a high incidence of gastric cancer. In the University digestive disease research center, the group of people is randomly selected and invited using the city's household health record. After obtaining consent, individuals are evaluated for Helicobacter pylori and treated if necessary. They are then randomly divided into intervention and control groups and followed for ten years for gastric cancer. Participants and follow-up and statistics groups are blinded.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Without a history of gastric cancer Resident in Ardabil Age 35 - 70 Willing to undergo the treatments and procedures described in the protocol Willing to provide necessary biological specimens Willing to sign an informed consent form Exclusion Criteria: History of Severe dyspepsia, peptic ulcer, and GI bleeding/ perforation History of NSAID gastritis Known allergy to any of the study medications Known medical conditions that could limit life expectancy
Intervention groups
Asprin and placebo group
Main outcome variables
Gastric cancer event

General information

Reason for update
The new sample size (21000 participants) was calculated and applied according to the updated information and executive restrictions.
Acronym
TELAPGC
IRCT registration information
IRCT registration number: IRCT201105082032N3
Registration date: 2017-04-21, 1396/02/01
Registration timing: registered_while_recruiting

Last update: 2023-01-03, 1401/10/13
Update count: 1
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Farhad Pourfarzi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 3325 9011
Email address
f.pourfarzi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
- Ministry of Health and Medical Education - Ardabil University of Medical Sciences
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2020-03-11, 1398/12/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Low-dose Aspirin in the Prevention of Gastric Cancer
Public title
The effect of Low-dose Aspirin in the Prevention of Gastric Cancer
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Living in the province for ten years Negative pregnancy test Willing to participate in the study Willing to provide biological specimens Willing to sign an informed consent form
Exclusion criteria:
No history of Gastric cancer History of Severe dyspepsia, peptic ulcer and GI bleeding/ perforation History of NSAID gastritis Known allergy to any of the study medications Known medical conditions that could limit life expectancy (eg. HIV/AIDS, congestive heart failure, renal failure, hepatic failure, current or prior malignancy, any other chronic disease that limits function) Prior esophageal malignancy, gastric ulcer or a gastrectomy (full or partial)
Age
From 35 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 21000
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible participants were randomly assigned to either aspirin or placebo groups with a 1:1 allocation ratio using permuted block randomization. Randomization was stratified by the initial HP status of subjects, baseline presence of intestinal metaplasia, and presence of two or more GC risk factors, to ensure recruitment balance between the two arms of the study. The permuted block sequence was generated with a block size of four. T
Blinding (investigator's opinion)
Double blinded
Blinding description
The provided medications, including aspirin and placebo, are small-sized white tablets. Aspirin and placebo bottles are both completely the same and labeled as “Artamed”. Both bottles contain 120 tablets, and the manufacturer prints a code on each bottle which can be used to determine the type of medication inside them. The codes were concealed in sealed and opaque envelopes with printed corresponding randomization numbers on them and kept safely in the study site with the personal investigator. DDRI provides and relabels the study drug and placebo to maintain the masking of the contents. The trial participants and care providers are blinded to the allocation. Staff independent of the study conduction enter data in the database using participants’ randomization codes so that outcome assessors and data analysts remain unaware of the treatment groups.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ardabil University of Medical Sciences
Street address
Daneshgah St
City
Ardabil
Province
Ardabil
Postal code
5618985991
Approval date
2017-03-05, 1395/12/15
Ethics committee reference number
IR.ARUMS.REC.1395.135

Health conditions studied

1

Description of health condition studied
Gastric Cancer
ICD-10 code
C16
ICD-10 code description
Malignant neoplasm of stomach

Primary outcomes

1

Description
Gastric Cancer
Timepoint
visits at first, 12 weeks, every 4 months, 5 years and 10 years
Method of measurement
Age standardized Incidence and Mortality Rate

Secondary outcomes

empty

Intervention groups

1

Description
Tablet Aspirin 81 mg (oral) Parsdarou company once daily
Category
Treatment - Drugs

2

Description
Placebo (Control):Tablet placebo (oral) Parsdarou company once daily
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil Cohort Studies Center
Full name of responsible person
Dr. Farhad Pourfarzi
Street address
Digestive Disease Research Center, 30 Tir St. Ardabil
City
اردبیل
Province
Ardabil
Postal code
5613658115
Phone
+98 45 3325 9011
Fax
+98 45 3326 2967
Email
farhad.pourfarzi@gmail.com
Web page address
https://research.arums.ac.ir/en/research-centers/ddrc/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ministry of Health and Medical Education
Full name of responsible person
Dr. Reza Malekzadeh
Street address
Ministry of Health and Medical Education
City
Tehran
Province
Tehran
Postal code
1467664961
Phone
+98 21 8145 5152
Email
dr.reza.malekzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ministry of Health and Medical Education
Proportion provided by this source
50
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Shahram Habibzadeh
Street address
Daneshgah St.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3352 2100
Fax
Email
s.habibzadeh@arums.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil University of Medical Sciences
Proportion provided by this source
10
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

3

Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Dr. Reza Malekzadeh
Street address
NIMAD, Besat St.
City
Tehran
Province
Tehran
Postal code
1419693111
Phone
+98 21 6690 0920
Fax
Email
nimad@research.ac.ir
Web page address
http://nimad.ac.ir/
Grant name
Grant code / Reference number
962245
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
National Institute for Medical Research Development
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Cancer Epidemiology
Street address
Daneshgah St.
City
Ardabil
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3325 9011
Fax
Email
f.pourfarzi@arums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad pourfarzi
Position
Principal Investigator / Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
Daneshgah St
City
اردبیل
Province
Ardabil
Postal code
5618985991
Phone
+98 45 3325 9011
Fax
Email
farhad.pourfarzi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Dr. Farhad Pourfarzi
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health/Community Medicine
Street address
Danshgah
City
Ardabil
Province
Ardabil
Postal code
5613658115
Phone
+98 45 3325 9011
Fax
Email
farhad.pourfarzi@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Loading...