RECRUITING

Colonoscopy vs Stool Testing for Older Adults With Colon Polyps

Conditions

Colorectal Polyp Colorectal Neoplasms Colorectal Adenoma Colorectal Cancer Digestive System Disease Colonoscopy Fecal immunochemical test (FIT)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a multi-site comparative effectiveness randomized controlled trial (RCT) comparing annual fecal immunochemical testing (FIT) and colonoscopy for post-polypectomy surveillance among adults aged 65-82 with a history of colorectal polyps who are due for surveillance colonoscopy.

Official Title

Colonoscopy Versus Stool-based Testing for Older Adults With a History of Colon Polyps

Quick Facts

Study Start:2023-06-14

Study Completion:2035-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05612347

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years to 82 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* English or Spanish speaking * Personal history of colorectal polyps * Most recent colonoscopy with ≤2 non-advanced polyps * Currently due or coming due within 12 months for colonoscopy * Able to provide written informed consent	* Personal history of colorectal cancer * Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome) * Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease) * Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps * Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year) * Patients unable to provide written informed consent

Inclusion Criteria

Exclusion Criteria

* English or Spanish speaking
* Personal history of colorectal polyps
* Most recent colonoscopy with ≤2 non-advanced polyps
* Currently due or coming due within 12 months for colonoscopy
* Able to provide written informed consent

* Personal history of colorectal cancer
* Personal history of genetic syndrome with high risk for colorectal cancer (e.g. Lynch Syndrome, Familial Adenomatous Polyposis Syndrome (FAP), or Serrated Polyposis Syndrome)
* Personal history of inflammatory bowel disease (e.g. ulcerative colitis, Crohn's disease)
* Most recent colonoscopy with advanced polyp(s) or ≥3 non-advanced polyps
* Patients unlikely to benefit from polyp surveillance (e.g., history of heart disease or coronary artery disease with treatment in the last 6 months, heart failure affecting function, lung disease requiring use of home oxygen, stroke within the last 4 months, dementia affecting activities of daily living (ADL) or instrumental activities of daily living (IADL), severe liver disease requiring the use of certain medications to control fluid, confusion, or bleeding, severe kidney disease requiring dialysis, or a new cancer diagnosis within the last year)
* Patients unable to provide written informed consent

Contacts and Locations

Study Contact

Kelsey M Veilleux, MD

CONTACT

(603) 650-0245

coopstudy@hitchcock.org

Principal Investigator

Audrey H Calderwood, MD, MS

PRINCIPAL_INVESTIGATOR

Dartmouth-Hitchcock Medical Center

Theodore R Levin, MD

PRINCIPAL_INVESTIGATOR

Kaiser Permante Northern California

Study Locations (Sites)

University of Alabama Birmingham

Birmingham, Alabama, 35233

United States

Kaiser Permanente Northern California

Walnut Creek, California, 94596

United States

University of Colorado

Aurora, Colorado, 80045

United States

Dartmouth Health

Lebanon, New Hampshire, 03756

United States

Kaiser Permanente Northwest

Portland, Oregon, 97232

United States

Collaborators and Investigators

Sponsor: Dartmouth-Hitchcock Medical Center

Audrey H Calderwood, MD, MS, PRINCIPAL_INVESTIGATOR, Dartmouth-Hitchcock Medical Center
Theodore R Levin, MD, PRINCIPAL_INVESTIGATOR, Kaiser Permante Northern California

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-14

Study Completion Date2035-12-31

Study Record Updates

Study Start Date2023-06-14

Study Completion Date2035-12-31

Terms related to this study

Keywords Provided by Researchers

Colonoscopy
Fecal immunochemical test (FIT)

Additional Relevant MeSH Terms

Colorectal Polyp
Colorectal Neoplasms
Colorectal Adenoma
Colorectal Cancer
Digestive System Disease