CTRI

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CTRI Number

CTRI/2024/03/063839 [Registered on: 08/03/2024] Trial Registered Prospectively

Last Modified On:

08/05/2024

Post Graduate Thesis

Type of Trial

Observational

Type of Study

Cohort Study

Study Design

Other

Public Title of Study

Should Colorectal Cancer screening be done in India?

Scientific Title of Study

Should Colorectal Cancer screening be done in Asymptomatic Indians: A Pan-India multicentre study.

Trial Acronym

NIL

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Dr Vineet Ahuja
Designation	Professor, Department of Gastroenterology and HNU, AIIMS Delhi
Affiliation	All India Institute of Medical Sciences, Delhi
Address	Department of Gastroenterology and Human Nutrition Unit, AIIMS Delhi, Sri Aurobindo Marg, Ansari Nagar, New Delhi New Delhi DELHI 110029 India
Phone	9810707170
Fax
Email	vineet.aiims@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Vineet Ahuja
Designation	Professor, Department of Gastroenterology and HNU, AIIMS Delhi
Affiliation	All India Institute of Medical Sciences, Delhi
Address	Department of Gastroenterology and Human Nutrition Unit, AIIMS Delhi, Sri Aurobindo Marg, Ansari Nagar, New Delhi New Delhi DELHI 110029 India
Phone	9810707170
Fax
Email	vineet.aiims@gmail.com

Details of Contact Person
Public Query

Name	Dr Vineet Ahuja
Designation	Professor, Department of Gastroenterology and HNU, AIIMS Delhi
Affiliation	All India Institute of Medical Sciences, Delhi
Address	Department of Gastroenterology and Human Nutrition Unit, AIIMS Delhi, Sri Aurobindo Marg, Ansari Nagar, New Delhi New Delhi DELHI 110029 India
Phone	9810707170
Fax
Email	vineet.aiims@gmail.com

Source of Monetary or Material Support

Indian Council of Medical Research (ICMR) V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India

Primary Sponsor

Name	Indian Council of Medical Research (ICMR)
Address	Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India.
Type of Sponsor	Government funding agency

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study

No of Sites = 8
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Subhash Chandra Samal	AIIMS Bhubaneshwar	Department of Gastroenterology,AIIMS Bhubaneshwar, Sijua, Patrapada, Bhubaneswar, Odisha 751019 Cuttack ORISSA	9938756409 subashsamal@hotmail.com
Dr Vineet Ahuja	AIIMS Delhi	Room no. 3183, Teaching block, Department of gastroenterology, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi 110029 New Delhi DELHI	9810707170 vineet.aiims@gmail.com
Dr Amit Kumar Dutta	Christian Medical College, Vellore	Department of Gastroenterology, Christian Medical College, IDA Scudder Rd, Vellore, Tamil Nadu 632004 Vellore TAMIL NADU	9488635210 akdutta1995@gmail.com
Dr Devesh Prakash Yadav	Institute of Medical Sciences, Banaras Hindu University	Department of Gastroenterology, IMS, Banaras Hindu University, Aurobindo Colony, Bhelupur, Varanasi, Uttar Pradesh 221005 Varanasi UTTAR PRADESH	8130856563 devesh.thedoc@gmail.com
Dr Mathew Philip	Lisie Institute of Gastroenterology, Hepatology and Transplantation (LIGHT), Lisie Hospital, Kochi	Department of Gastroenterology,Lisie Institute of Gastroenterology, Hepatology and Transplantation (LIGHT), Lisie Hospital, Kochi, Lisie Hospital Rd, North Kaloor, Kaloor, Ernakulam, Kerala 682018 Ernakulam KERALA	9846045469 drmathewphilip@gmail.com
Dr Usha Dutta	Postgraduate Institute of Medical Education and Research	Department of gastroenterology,Postgraduate Institute of Medical Education and Research, Madhya Marg, Sector 12, Chandigarh 160012 Chandigarh CHANDIGARH	8198877022 ushadutta@gmail.com
Dr Rupesh Pokharna	Sawai Man Singh Medical College	Department of Gastroenterology, Sawai Man Singh Medical College, New Sms Campus Rd, Gangawal Park, Adarsh Nagar, Jaipur, Rajasthan 302004 Jaipur RAJASTHAN	1412708837 rkpokharna2@rediffmail.com
Dr Shubham Jain	Topiwala National Medical College	Department of Gastroenterology, Topiwala National Medical College and Dr B.Y.L. Charitable Hospital, Dr A.L, Dr Anandrao Nair Marg, Mumbai Central, Mumbai, Maharashtra 400008 Mumbai MAHARASHTRA	7710915754 dr.shubhamjazz@gmail.com

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 8
Name of Committee	Approval Status
BYL Nair & TNMC, Institutional Ethics Committee	Approved
Institute Ethics Committee AIIMS Bhubaneshwar	Approved
Institute Ethics Committee AIIMS Delhi	Approved
Institute Ethics Committee BHU	Approved
Institute Ethics Committee CMC Vellore	Submittted/Under Review
Institute Ethics Committee Lisie Hospital	Approved
PGIMER Institutional Ethics Committee	Approved
SMSMC Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Healthy Human Volunteers	Healthy asymptomatic adults (Absence of weight loss, persistent fever, anaemia, diarrhoea, rectal bleeding, constipation (within past 1 year), persistent abdominal pain).

Intervention / Comparator Agent

Type	Name	Details
Intervention	NA	NA
Comparator Agent	NA	NA

Inclusion Criteria

Age From	50.00 Year(s)
Age To	75.00 Year(s)
Gender	Both
Details	1. Healthy asymptomatic adults aged between 50-75 years.(Absence of following symptoms: weight loss, persistent fever, anaemia, diarrhoea, rectal bleeding, constipation (recent onset within past 1 year), persistent abdominal pain). 2. Written Informed consent.

ExclusionCriteria

Details

1.Prior diagnosis of cancer
2.Family history of CRC: those with recognised familial genetic syndromes;those having FDRs with documented advanced adenomas.
3.Inflammatory Bowel Disease
4.Colonoscopy, gFOBT,FIT, sigmoidoscopy, barium enema done within the last 10 years
5.Recent onset of lower gastrointestinal tract symptoms (bleeding, change in bowel habit, abdominal pain, weight loss, bloating, anaemia) causing healthcare attendance in the previous 12 months.
6.Significant comorbidity (American Society of Anaesthesiologists class III or greater)
7.Previous gastrointestinal surgery
8.Participation in any other clinical trial in the previous 3 months
9.A person unlikely to be compliant or unable to give informed consent

Method of Generating Random Sequence

Method of Concealment

Blinding/Masking

Primary Outcome

Outcome	TimePoints
To evaluate the prevalence of advanced colorectal neoplasia or colorectal cancer in asymptomatic healthy adults aged 50-75 years by adopting a modified risk score based screening strategy in India.	Baseline, Follow up 1st year, Follow up 2nd year

Secondary Outcome

Outcome	TimePoints
To evaluate the prevalence of all forms of colorectal polyps in asymptomatic healthy adults.	Baseline, Follow up 1st year, Follow up 2nd year
To evaluate the cost effectiveness or benefit of adopting a risk score based screening strategy.	Baseline, Follow up 1st year, Follow up 2nd year
To identify the contribution of each risk factor for occurrence of advanced colorectal neoplasia or colorectal cancer.	Baseline, Follow up 1st year, Follow up 2nd year

Target Sample Size

Total Sample Size="6500"
Sample Size from India="6500"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"

Phase of Trial

N/A

Date of First Enrollment (India)

01/04/2024

Date of Study Completion (India)

Applicable only for Completed/Terminated trials

Date of First Enrollment (Global)

Date Missing

Date of Study Completion (Global)

Applicable only for Completed/Terminated trials

Estimated Duration of Trial

Years="4"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Applicable

Recruitment Status of Trial (India)

Not Yet Recruiting

Publication Details

N/A

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

Rationale of study: The true prevalence of advanced colorectal neoplasm in an asymptomatic healthy population is unknown. We look to explore the prevalence, and cost effectiveness and devise a rational screening strategy for CRC in India using a validated risk score based approach.

Hypothesis/Research Question:

Â· What is the true prevalence of advanced colorectal neoplasia or CRC in asymptomatic healthy individuals in the general population?

Â· What is the benefit of adopting a risk score based screening strategy in India?

Objective: To primarily evaluate the prevalence of advanced colorectal neoplasia or colorectal cancer in asymptomatic healthy adults aged 50-75 years by adopting a modified risk based scoring strategy in India. Secondary outcomes would include knowing the prevalence of all forms of colorectal polyps, evaluating the screening strategy’s cost effectiveness and identifying risk factors’ contribution.

Expected Outcomes: To know the true prevalence of advanced colorectal neoplasia/colorectal cancer in asymptomatic healthy adults in India and devise a rational screening strategy for CRC in India.

Methods: All asymptomatic healthy adults aged 50-75 would be invited to participate in this screening study. Exclusions would include any prior diagnosis of cancer, family history of CRC, Inflammatory Bowel Disease, Colonoscopy or gFOBT or FIT or Sigmoidoscopy/ Barium study done within the last 10 years, any recent onset of lower gastrointestinal tract symptoms, previous gastrointestinal surgery and unlikely to be compliant or unable to give informed consent.