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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 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years

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)

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Dartmouth-Hitchcock Medical CenterLead Sponsor

524 Previous Clinical Trials

2,531,843 Total Patients Enrolled

Patient-Centered Outcomes Research InstituteOTHER

551 Previous Clinical Trials

29,988,512 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many research centers are participating in this experiment?

"There are 5 main sites for this trial, including the University of Colorado in Aurora, University of Alabama Birmingham in Birmingham and Kaiser Permanente Northwest in Portland. Additionally, there is a further selection of clinical centres offering access to this study."

Answered by AI

Does this research project permit individuals aged 65 and above to participate?

"This clinical trial has set the age range at 70 to 82. Of the registered studies, 66 are applicable for those under 18 and 1201 apply to those above 65 years of age."

Answered by AI

Is it possible for me to join this experiment?

"This research project requires 8946 participants, aged between 70 and 82 years old, with existing hepatobiliary conditions. Furthermore, the individuals must be bilingual in either English or Spanish; they must have a personal history of colorectal polyps; their last colonoscopy had to contain less than 2 non-advanced polyps; they need to be due for/coming due within 12 months for another colonoscopy; and sign a document that provides written informed consent."

Answered by AI

Are participants currently being accepted for this experiment?

"According to the information posted on clinicaltrials.gov, this experiment is no longer recruiting participants. The trial was initially listed on February 1st 2023 and last amended on November 4th 2022; however, there are 1236 other trials actively looking for patients at present."

Answered by AI

Recent research and studies

GastroenterologyJournal

Recommendations for Follow-up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-society Task Force on Colorectal Cancer

Gupta, Samir, David Lieberman, Joseph C. Anderson, Carol A. Burke, Jason A. Dominitz, Tonya Kaltenbach, Douglas J. Robertson, Aasma Shaukat, Sapna Syngal, and Douglas K. Rex. 2020. “Recommendations for Follow-up After Colonoscopy and Polypectomy: A Consensus Update by the US Multi-society Task Force on Colorectal Cancer”. Gastroenterology. Elsevier BV. doi:10.1053/j.gastro.2019.10.026.

clinicaltrials.govStudy

Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

Audrey H. Calderwood 2023. "Colonoscopy vs Stool Testing for Older Adults With Colon Polyps". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05612347.

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