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RECRUITING

NCT05080673

Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps

Sponsor: NRG Oncology

View on ClinicalTrials.gov

Summary

This trial examines colorectal cancer incidence in participants with 1 to 2 non-advanced adenomas randomized to surveillance colonoscopy at 10 years compared to participants randomized to surveillance colonoscopy at 5 and 10 years.

Key Details

Gender

All

Age Range

45 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

9500

Start Date

2022-02-09

Completion Date

2065-11-01

Last Updated

2026-08-04

Healthy Volunteers

Conditions

Adenocarcinoma of the Colon Adenocarcinoma of the Rectum

Interventions

PROCEDURE

5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy

The five- and ten-year colonoscopies, in addition to any unscheduled colonoscopies, will be performed according to currently accepted guidelines for the performance of quality colonoscopy. Participants will be given the standardized colonoscopy preparation instructions per institutional standards.

Inclusion Criteria: * The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines. * Participants greater than or equal to 45 and less than 70 years of age at the time of colonoscopy. * Participants with a first-time diagnosis of 1-2 non-advanced tubular adenomas (less than 10 mm without tubulovillous or villous changes or high grade or severe dysplasia) from the qualifying colonoscopy within 4 years prior to randomization. * Sessile serrated polyps/adenomas, as long as they do not meet the criteria for advanced adenomas, will be considered as non-advanced adenomas. * Qualifying colonoscopy must be a complete colonoscopy with visualization of the cecum and with adequate cleansing within 4 years prior to randomization. * Complete excision of all observed polyps in qualifying colonoscopy * Participants must be able to read or understand English or Spanish. Exclusion Criteria: * • Prior history of colorectal cancer or colorectal adenomas including sessile serrated polyps/adenomas excluding those found on the qualifying colonoscopy. * Prior history of a hyperplastic polyp measuring greater than or equal to 1 cm in size. * Traditional serrated adenomas found on the qualifying colonoscopy. * Hyperplastic polyp measuring greater than or equal to 1 cm in size found on the qualifying colonoscopy. * Previous malignancies unless the patient has been disease-free for 5 or more years prior to randomization and is deemed by the physician to be at low risk for recurrence. Patients with the following cancers are eligible if diagnosed and treated within the past 5 years: all in situ cancers and basal cell and squamous cell carcinoma of the skin. * Colonoscopy performed after the qualifying colonoscopy but prior to randomization. * Incomplete qualifying colonoscopy (e.g., cecum not visualized). * Incomplete endoscopic excision of adenomatous polyps based on colonoscopist impression at qualifying colonoscopy. (Excision of all hyperplastic rectosigmoid polyps is not required.) * Sub-total colectomy or total proctocolectomy. (Segmental resections are allowed.) * Family history of CRC diagnosed at less than or equal to 60 years of age in a first degree relative (mother, father, child, sibling) or in two first degree relatives with CRC at any age. * Participants with a clinical diagnosis of a significant heritable risk for colorectal cancer (Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\]). * Participants tested positive for a Familial Adenomatous Polyposis, Hereditary Nonpolyposis Colorectal Cancer \[Lynch Syndrome\] genetic mutation that increases risk of colorectal cancer. * Inflammatory bowel disease (e.g., Crohn's Disease, ulcerative colitis). * Life expectancy less than 10 years due to comorbid conditions in the opinion of the investigator. * Other comorbid conditions that would prevent the participant from having colonoscopies or would prevent required follow-up.

Locations (485)

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Kingman Regional Medical Center

Kingman, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

University of Arizona Cancer Center - Prevention Research Clinic

Tucson, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Kaiser Permanente-Anaheim

Anaheim, California, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

PCR Oncology

Arroyo Grande, California, United States

Kaiser Permanente-Baldwin Park

Baldwin Park, California, United States

Kaiser Permanente-Bellflower

Bellflower, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Epic Care-Dublin

Dublin, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Bay Area Breast Surgeons Inc

Emeryville, California, United States

Epic Care Partners in Cancer Care

Emeryville, California, United States

Kaiser Permanente-Fontana

Fontana, California, United States

Kaiser Permanente South Bay

Harbor City, California, United States

Kaiser Permanente-Irvine

Irvine, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Kaiser Permanente West Los Angeles

Los Angeles, California, United States

UCLA / Jonsson Comprehensive Cancer Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Mercy Cancer Center

Merced, California, United States

Alta Bates Summit Medical Center - Summit Campus

Oakland, California, United States

Bay Area Tumor Institute

Oakland, California, United States

Kaiser Permanente-Ontario

Ontario, California, United States

Stanford Cancer Institute Palo Alto

Palo Alto, California, United States

Kaiser Permanente - Panorama City

Panorama City, California, United States

Kaiser Permanente-Riverside

Riverside, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

Kaiser Permanente-San Diego Mission

San Diego, California, United States

Kaiser Permanente-San Diego Zion

San Diego, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Kaiser Permanente-San Marcos

San Marcos, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

Kaiser Permanente-Vallejo

Vallejo, California, United States

Epic Care Cyberknife Center

Walnut Creek, California, United States

BASS Medical Group - Lennon

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Kaiser Permanente-Woodland Hills

Woodland Hills, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

Rocky Mountain Regional VA Medical Center

Aurora, Colorado, United States

UCHealth University of Colorado Hospital

Aurora, Colorado, United States

Boulder Community Foothills Hospital

Boulder, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Rocky Mountain Cancer Centers - Centennial

Centennial, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

Kaiser Permanente-Franklin