Implementation of a population-level colonoscopic screening in first-degree relatives of colorectal cancer patients in Golestan province of Iran: Feasibility and Effectiveness
Results of the Golestan population-based cancer registry suggested a considerable increasing trend in incidence of colorectal cancer (CRC) in Golestan province during the last decade. CRC screening in high-risk individuals may be effective in reducing the CRC incidence and mortality. We aimed to assess the feasibility and effectiveness of implementation of colonoscopic screening in first-degree relatives of CRC patients in Golestan.
Design
This study is a phase III Parallel design controlled trial. This study includes two arms including intervention and control arms. The sample size of each arm is 500 subjects.
Settings and conduct
Subjects will be informed about importance of colonoscopy in CRC control. Subjects who accepted to perform colonoscopy will be recruited in intervention group and others, will be recruited in control arm. Subjects in intervention group will be referred for screening colonoscopy. Biopsy samples will be taken from abnormal pathologic lesions. Appropriate treatment will be considered for subjects with abnormal lesions. All participants in the intervention and control groups will be followed annually. If there is any possible evidence of developing cancer or death in each subject, the follow up team will collect supportive documents to define the exact cause of death or type of cancer. Participants in both groups will be followed for 5 years. At the end of the study, the outcomes of interest will be compared between intervention and control arms.
Participants/Inclusion and exclusion criteria
Inclusion: History of CRC in first degree relatives, age below 75 years
Exclusion: History of malignancy, contraindications of colonoscopy, history of cirrhosis, renal failure.
Intervention groups
Colonoscopic examination, taking biopsy and pathological examination of abnormal lesions, Removal of polyps
Main outcome variables
Development of CRC and death from CRC
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120225009124N3
Registration date:2018-12-24, 1397/10/03
Registration timing:registered_while_recruiting
Last update:2018-12-24, 1397/10/03
Update count:0
Registration date
2018-12-24, 1397/10/03
Registrant information
Name
Gholamreza Roshandel
Name of organization / entity
Golestan University of Medical Sciences/ Golestan Research Center of Gastroenterology and Hepatology
Country
Iran (Islamic Republic of)
Phone
+98 17 3225 1910
Email address
roshandel@goums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Implementation of a population-level colonoscopic screening in first-degree relatives of colorectal cancer patients in Golestan province of Iran: Feasibility and Effectiveness
Public title
Colonoscopic screening for colorectal cancer
Purpose
Screening
Inclusion/Exclusion criteria
Inclusion criteria:
Having history of colorectal cancer in first degree relative
Age lower than 75
Exclusion criteria:
Personal history of malignancy
Contraindications of colonoscopy
Personal history of cirrhosis
Personal history of renal failure
Age
To 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
1000
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commiittee of the National Institute for Medical Medical Research Development
Street address
West Fatemi
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2016-10-14, 1395/07/23
Ethics committee reference number
IR.NIMAD.REC.1395.011
Health conditions studied
1
Description of health condition studied
Colorectal cancer
ICD-10 code
C18.9
ICD-10 code description
Malignant neoplasm of colon, unspecified
Primary outcomes
1
Description
Incidence of Colorectal cancer
Timepoint
3 years
Method of measurement
All participants in the intervention and control groups will be followed annually. Each subject will annually be contacted by a telephone call, and questions about the subject’s vital status and cancer incidence will be asked. If there is any possible evidence of developing cancer or death in each subject, the follow up team will collect supportive documents (from patient's hospital files,...) to define the exact cause of death or type of cancer.
Secondary outcomes
1
Description
CRC mortality
Timepoint
End of study follow up
Method of measurement
Telephone follow up and confirmation by reviewing patients' documents and files
Intervention groups
1
Description
Intervention group: Colonoscopy. The subjects will receive screening colonoscopic examination. In case of any abnormal pathological findings, appropriate treatment will be considered for the subject
Category
Prevention
2
Description
Control group: No colonoscopy
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Omid Preventive Medicine and Health Promotion Center
Full name of responsible person
Gholamreza Roshandel
Street address
5th floor, Edalat 11, Mousavi hospital
City
Gorgan
Province
Golestan
Postal code
4916653588
Phone
+98 17 3225 1910
Email
roshandel_md@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
National Institute for Medical Research Development
Full name of responsible person
Professor Reza Malekzadeh
Street address
Number 21, Fatemi gharbi
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Phone
+98 21 6693 8037
Email
NIMAD@RESEARCH.AC.IR
Grant name
Grant code / Reference number
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
100
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
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Roshandel
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Sayyad Shirazi Bolevard, Sayyad Shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Email
roshandel_md@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Gholamreza Roshandel
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Sayyad Shirazi Bolevard, Sayyad Shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Fax
Email
roshandel_md@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Gorgan University of Medical Sciences
Full name of responsible person
Dr Gholamreza Roshandel
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
Sayyad Shirazi Bulevard, Sayyad Shirazi hospital
City
Gorgan
Province
Golestan
Postal code
4917867439
Phone
+98 17 3225 1910
Fax
Email
roshandel_md@yahoo.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