Adenocarcinoma of the ColonAdenocarcinoma of the Rectum
Investigational drug(s) / intervention(s)
5-year and 10 Year Surveillance Colonoscopy after Qualifying Colonoscopy
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.
Study 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.
Eligibility
Sex
ALL
Min age
45 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Incidence of colorectal cancer — 10 years To examine 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.
Trial sites (493)
Facility
City
Region
Status
Fairbanks Memorial Hospital
Fairbanks
Alaska
Active Not Recruiting
CTCA at Western Regional Medical Center
Goodyear
Arizona
Recruiting
Kingman Regional Medical Center
Kingman
Arizona
Recruiting
Cancer Center at Saint Joseph's
Phoenix
Arizona
Recruiting
University of Arizona Cancer Center - Prevention Research Clinic
Tucson
Arizona
Recruiting
Mercy Hospital Fort Smith
Fort Smith
Arkansas
Recruiting
CHI Saint Vincent Cancer Center Hot Springs
Hot Springs
Arkansas
Suspended
CARTI Cancer Center
Little Rock
Arkansas
Recruiting
Kaiser Permanente-Anaheim
Anaheim
California
Recruiting
Mission Hope Medical Oncology - Arroyo Grande
Arroyo Grande
California
Recruiting
PCR Oncology
Arroyo Grande
California
Recruiting
Kaiser Permanente-Baldwin Park
Baldwin Park
California
Recruiting
Kaiser Permanente-Bellflower
Bellflower
California
Recruiting
Mercy Cancer Center - Carmichael
Carmichael
California
Recruiting
Mercy San Juan Medical Center
Carmichael
California
Recruiting
Epic Care-Dublin
Dublin
California
Active Not Recruiting
Mercy Cancer Center - Elk Grove
Elk Grove
California
Recruiting
Bay Area Breast Surgeons Inc
Emeryville
California
Active Not Recruiting
Epic Care Partners in Cancer Care
Emeryville
California
Active Not Recruiting
Kaiser Permanente-Fontana
Fontana
California
Recruiting
Kaiser Permanente South Bay
Harbor City
California
Recruiting
Kaiser Permanente-Irvine
Irvine
California
Recruiting
Kaiser Permanente Los Angeles Medical Center
Los Angeles
California
Recruiting
Kaiser Permanente West Los Angeles
Los Angeles
California
Recruiting
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles
California
Recruiting
Contra Costa Regional Medical Center
Martinez
California
Recruiting
Mercy Cancer Center
Merced
California
Recruiting
Alta Bates Summit Medical Center - Summit Campus
Oakland
California
Suspended
Bay Area Tumor Institute
Oakland
California
Active Not Recruiting
Kaiser Permanente-Ontario
Ontario
California
Recruiting
Stanford Cancer Institute Palo Alto
Palo Alto
California
Recruiting
Kaiser Permanente - Panorama City
Panorama City
California
Recruiting
Kaiser Permanente-Riverside
Riverside
California
Recruiting
Mercy Cancer Center - Rocklin
Rocklin
California
Recruiting
Mercy Cancer Center - Sacramento
Sacramento
California
Recruiting
Kaiser Permanente-Rio San Diego
San Diego
California
Recruiting
Kaiser Permanente-San Diego Zion
San Diego
California
Recruiting
Pacific Central Coast Health Center-San Luis Obispo
San Luis Obispo
California
Recruiting
Kaiser Permanente-San Marcos
San Marcos
California
Recruiting
Mission Hope Medical Oncology - Santa Maria
Santa Maria
California
Recruiting
+ 453 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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