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Colonoscopy vs Stool Testing for Colorectal Polyps (COOP Trial)

N/A
Recruiting
Led By Theodore R Levin, MD
Research Sponsored by Dartmouth-Hitchcock Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years
Awards & highlights

COOP Trial Summary

This trial compares two ways to monitor colon health after polyps are removed: FIT testing & colonoscopy. People aged 70-82 with a history of polyps can take part.

Who is the study for?
Adults aged 70-82 with a history of one or two non-advanced colorectal polyps and due for surveillance colonoscopy can join. They must speak English or Spanish and be able to consent. Those with serious heart, lung, liver, kidney diseases, dementia affecting daily activities, recent stroke or cancer diagnosis are excluded.Check my eligibility
What is being tested?
The trial is comparing yearly stool tests (FIT) versus the standard colonoscopy to monitor older adults who previously had colon polyps. It's a randomized controlled trial across multiple sites where participants are randomly assigned to either method.See study design
What are the potential side effects?
Colonoscopy may cause discomfort, bleeding, or perforation of the colon wall in rare cases. Stool testing (FIT) is generally safe but may lead to follow-up procedures like a colonoscopy if results indicate abnormal findings.

COOP Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Advance Directives
Secondary outcome measures
Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)
Colorectal Carcinoma
Change from baseline Satisfaction and Trust of colorectal screening testing assessed by Tiro et al (2005) Response Efficacy sub-scale from the general colorectal cancer screening survey.
+3 more

COOP Trial Design

2Treatment groups
Active Control
Group I: FITActive Control1 Intervention
FIT (annual)
Group II: ColonoscopyActive Control1 Intervention
Surveillance colonoscopy (one time)

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor
528 Previous Clinical Trials
2,532,430 Total Patients Enrolled
Patient-Centered Outcomes Research InstituteOTHER
556 Previous Clinical Trials
29,938,860 Total Patients Enrolled
Theodore R Levin, MDPrincipal InvestigatorKaiser Permante Northern California
2 Previous Clinical Trials
50,000 Total Patients Enrolled

Media Library

Colonoscopy Clinical Trial Eligibility Overview. Trial Name: NCT05612347 — N/A
Colorectal Cancer Research Study Groups: FIT, Colonoscopy
Colorectal Cancer Clinical Trial 2023: Colonoscopy Highlights & Side Effects. Trial Name: NCT05612347 — N/A
Colonoscopy 2023 Treatment Timeline for Medical Study. Trial Name: NCT05612347 — N/A
~5964 spots leftby Dec 2028
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