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Colonoscopy vs FIT Screening for Colorectal Cancer (CONFIRM Trial)
N/A
Waitlist Available
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male and female adults aged 50-75 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
CONFIRM Trial Summary
This trial will compare the effectiveness of two ways to screen for colorectal cancer: colonoscopy (invasive, expensive, requires prep) and fecal immunochemical testing (FIT, non-invasive, inexpensive, no prep).
Who is the study for?
This trial is for men and women aged 50-75, preferably veterans, who can consent to the study. It's not for those with severe health issues that make screening risky or unnecessary, pregnant individuals, people without a stable address, or anyone with a recent history of colon disease or tests.Check my eligibility
What is being tested?
The CONFIRM trial is comparing two colorectal cancer screening methods: annual fecal immunochemical tests (FIT) and colonoscopy. The goal is to see which method better reduces death from this cancer over ten years in people at average risk.See study design
What are the potential side effects?
Colonoscopy may cause complications like bleeding or tears in the colon wall; however these are rare. FIT involves collecting stool samples at home and has no direct side effects but may lead to further testing if results are positive.
CONFIRM Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 50 and 75 years old.
CONFIRM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 10 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The is colorectal cancer mortality.
Secondary outcome measures
FIT Positive - If Colonoscopy is Warranted
CONFIRM Trial Design
2Treatment groups
Experimental Treatment
Group I: Arm 2Experimental Treatment1 Intervention
FIT (annually)
Group II: Arm 1Experimental Treatment1 Intervention
Colonoscopy (one time screening)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
FIT
2022
Completed Phase 2
~13520
Colonoscopy
2012
Completed Phase 3
~115560
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,609 Previous Clinical Trials
3,256,477 Total Patients Enrolled
Jason A. Dominitz, MD MHSStudy ChairVA Puget Sound Health Care System Seattle Division, Seattle, WA
Douglas J Robertson, MD MPHStudy ChairWhite River Junction VA Medical Center, White River Junction, VT
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a history of colon issues like IBD, polyps, cancer, or surgery.I do not have severe health issues that would make colonoscopy risky for me.I am between 50 and 75 years old.I have symptoms like rectal bleeding, anemia, or significant weight loss that require a colonoscopy.I have had a colon check-up in the recommended timeframe.
Research Study Groups:
This trial has the following groups:- Group 1: Arm 2
- Group 2: Arm 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT01239082 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Am I eligible to become a participant in this research study?
"This medical trial aims to recruit 50126 individuals with colorectal cancer in the age range of 50-75. To be eligible, patients must satisfy the criteria that they are adult males or females within this specified age bracket."
Answered by AI
Are there any patient vacancies available in this experiment?
"Evidenced on clinicaltrials.gov, this trial is not presently enlisting patients. Initially posted on April 30th 2012 and most recently updated March 1st 2022, the study isn't currently accepting applications though there are 1064 other research projects actively recruiting participants at present."
Answered by AI
At how many sites is this experimental protocol currently being implemented?
"The study is being carried out within the Louis Stokes VA Medical Centre in Cleveland, Ohio; Philadelphia Multi Service Center in Pennsylvania; Orlando VA Medical Centre in Florida and 45 other locations."
Answered by AI
Does this research endeavor encompass individuals over the age of 35?
"As per the requirements for this study, all participants must be between 50 and 75 years old."
Answered by AI
Who else is applying?
What state do they live in?
Missouri
Arizona
Other
Texas
How old are they?
65+
18 - 65
What site did they apply to?
Phoenix VA Health Care System, Phoenix, AZ
Atlanta VA Medical and Rehab Center, Decatur, GA
Michael E. DeBakey VA Medical Center, Houston, TX
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
1
Why did patients apply to this trial?
Need my first colon cancer test. I volunteer for studies when I can partly because my daughter is a doctor and I can use the extra money for medical bills.
PatientReceived no prior treatments
Recent research and studies
American Journal of GastroenterologyJournal
ACG Clinical Guidelines: Colorectal Cancer Screening 2021Other Trials to Consider
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