Protocol summary

Summary
We studied the first degree relatives of gastric cancer patients , aged 40_65 years old, who had gastritis but no peptic ulcer in endoscopy. Their gastritis didn’t limit to antrum. Six locations in stomach (lesser curvature_ mid antrum, lesser curvature_ angulus, lesser curvature_ mid body, grater curvature_mid antrum, grater curvature_ angulus, grater curvature _mid body) were biopsied. Patients with precancerous lesions and helicobacter pylori infection were entered into study. from 1020 patients, 480 patients who were entered, were divided into two groups randomaly. 240 patients as case group treated with 500mg Amoxicillin, 20mg Omeprazol, 240 mg Bismute and 500 mg Metronidazol, twice a day, for 2 weeks. 240 patients as control group treated with placebo. Patients were observed with UBT for helicobacter pylori eradication 6_8 weeks later and endoscopy were done for them after one year. Two groups (case_ control) were compared for cancerous lesions after a year.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138706131155N2
Registration date: 2009-01-30, 1387/11/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-01-30, 1387/11/11
Registrant information
Name
Farahnaz Joukar
Name of organization / entity
Guilan University of Medical Sciences, Gastrointestinal and liver disease Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 1553 5116
Email address
info@gldrc.org
Recruitment status
Recruitment complete
Funding source
Gastrointestinal and Liver Diseases Research Center (GLDRC)
Expected recruitment start date
2004-08-05, 1383/05/15
Expected recruitment end date
2005-08-05, 1384/05/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of helicobacter pylori eradication on regression of gastric precancerous lesion in 1st degree relatives of patients with gastric cancer
Public title
Effect of helicobacter pylori eradication on regression of gastric precancerous lesion in 1st degree relatives of patients with gastric cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1st degree relatives of patients with gastric cancer (father , mother, sister and brother. son and doughter), aged 40-65 years old, with gastritis, dont limit to antrum, and precancerous lesions with helicobacter pylori infection, giving informed consent. Exclusion criteria: cases of gastric cancer, peptic ulcer with endoscopic evidence, history of gasterctomy, chronic or serious medical diseases (renal failure, CHD, liver disease, etc )
Age
From 40 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 480
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
Secondary trial Id
Registration date
2017-11-21, 1396/08/30

Ethics committees

1

Ethics committee
Name of ethics committee
Gastrointestinal and Liver Diseases Research Center
Street address
Gastrointestinal and Liver Diseases Research Center- Razi Hospital - Sardar Jangal Ave-Rasht-Iran
City
Rasht
Postal code
41448-95655
Approval date
2004-02-05, 1382/11/16
Ethics committee reference number
114

Health conditions studied

1

Description of health condition studied
Gasteric Cancer
ICD-10 code
c16
ICD-10 code description
Malignant neoplasm of stomach

Primary outcomes

1

Description
Eradication of helicobacter pylori
Timepoint
6-8 weeks after treatment
Method of measurement
UBT

2

Description
Regression of precancerous lesions
Timepoint
one year after onset of treatment
Method of measurement
endoscopy and pathology

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group reciverd Omeprazol 20mg, Bismut 240mg, metronidazol 500mg,amoxicillin 1gr twice a day for 2 week
Category
empty

2

Description
Control group recived plasebo
Category
empty

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanaei
Street address
Gastrointestinal and Liver Diseases Research Center- Razi hospital - Sardar Jangal ave.
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Guilan Govermental Province
Full name of responsible person
Farahnaz Joukar
Street address
Guilan Govermental Province- Moalem ave.
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Guilan Govermental Province
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Farahnaz Joukar
Position
Assistant of Gastrointestinal and Liver Diseases Research Center
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center- Razi hospital - Sardar Jangal Ave-Rasht-Iran
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
Email
F_Jokar@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for scientific inquiries

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Fariborz Mansour-Ghanei
Position
Full Professor of Internal Medicine & gastroenterology
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center- Razi Hospital - Sardar Jangal Ave-Rasht-Iran
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
Email
Ghanaei@gums.ac.ir
Web page address
www.gldrc.org

Person responsible for updating data

Contact
Name of organization / entity
Gastrointestinal and Liver Diseases Research Center
Full name of responsible person
Dr.Helia Valaee Barhagh
Position
Doctor/ Researcher
Other areas of specialty/work
Street address
Gastrointestinal and Liver Diseases Research Center- Razi Hospital - Sardar Jangal Ave-Rasht-Iran
City
Rasht
Postal code
41448-95655
Phone
+98 13 1553 5116
Fax
Email
HeliaValaee@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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