Trial Title:
Colonoscopy vs Stool Testing for Older Adults With Colon Polyps
NCT ID:
NCT05612347
Condition:
Colorectal Polyp
Colorectal Neoplasms
Colorectal Adenoma
Colorectal Cancer
Digestive System Disease
Conditions: Official terms:
Colorectal Neoplasms
Adenoma
Digestive System Diseases
Gastrointestinal Diseases
Polyps
Conditions: Keywords:
Colonoscopy
Fecal immunochemical test (FIT)
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
FIT
Description:
Annual FIT
Arm group label:
FIT
Intervention type:
Diagnostic Test
Intervention name:
Colonoscopy
Description:
One time surveillance colonoscopy
Arm group label:
Colonoscopy
Summary:
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.
Detailed description:
Colon polyps are common among adults ≥50 years and people with colon polyps are
recommended to undergo regular follow-up colonoscopy (surveillance) in hopes of
preventing subsequent colorectal cancer (CRC). Older adults, particularly those who are
age ≥70 years, most of whom have a history of only small colon polyps, may benefit little
from repeated colonoscopies because of the increased risks of colonoscopy due to age and
co-morbidities and potentially limited life expectancy due to other competing medical
problems - CRC may never be a problem for them. Older adults may also be hesitant to get
repeated colonoscopy because of the risk of complications (e.g., bleeding, perforation,
etc.) and inconvenience. More surveillance options are needed to help address the
concerns and challenges with repeated colonoscopies in older adults with a history of
low-risk polyps.
FIT is a noninvasive, stool-based test that is recommended and widely used in the US and
globally for CRC screening in average-risk adults 45 to 75 years of age. In addition, FIT
is already standard of care as a surveillance option for patients with a history of
low-risk adenomas in Canada and has been shown to be equivalent to colonoscopy for
screening of certain high-risk populations (e.g., those with a family history of CRC).
However, FIT's role for surveillance among older adults who have a history of low-risk
adenomas has not been studied in the US nor among older adults who may benefit from this
noninvasive surveillance approach.
The COOP Trial will fill this evidence gap and shed light on patient-, clinician-, and
system-factors relevant to FIT for surveillance that together could potentially transform
surveillance guidelines in the US and beyond
The purpose of this study is to compare annual at-home stool-based testing, with a fecal
immunochemical test (FIT), to colonoscopy in adults age 65-82 who have a history of
colorectal polyps. The goal of the study is to compare how well FIT works compared to
colonoscopy in looking for and finding colorectal cancer in older adults who have a
history of colorectal polyps, as well as to understand people's experiences with using it
compared to colonoscopy.
Criteria for eligibility:
Criteria:
Inclusion 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
Exclusion Criteria:
- 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
Gender:
All
Minimum age:
65 Years
Maximum age:
82 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Alabama Birmingham
Address:
City:
Birmingham
Zip:
35233
Country:
United States
Status:
Recruiting
Contact:
Last name:
Douglas Morgan, MD, MPH
Contact backup:
Last name:
Tatiana Torres Herman
Email:
ttherman@uabmc.edu
Facility:
Name:
Kaiser Permanente Northern California
Address:
City:
Walnut Creek
Zip:
94596
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jeffrey Lee, MD, MPH
Facility:
Name:
University of Colorado
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Contact:
Last name:
Swati Patel, MD, MS
Facility:
Name:
Dartmouth Health
Address:
City:
Lebanon
Zip:
03756
Country:
United States
Status:
Recruiting
Contact:
Last name:
Audrey Calderwood, MD, MS
Facility:
Name:
Kaiser Permanente Northwest
Address:
City:
Portland
Zip:
97232
Country:
United States
Status:
Active, not recruiting
Start date:
June 14, 2023
Completion date:
December 31, 2035
Lead sponsor:
Agency:
Dartmouth-Hitchcock Medical Center
Agency class:
Other
Collaborator:
Agency:
Patient-Centered Outcomes Research Institute
Agency class:
Other
Source:
Dartmouth-Hitchcock Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05612347
