RECRUITINGINTERVENTIONAL
Five or Ten Year Colonoscopy for 1-2 Non-Advanced Adenomatous Polyps
About This Trial
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.
Who May Be Eligible (Plain English)
Who May Qualify:
- 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.
Who Should NOT Join This Trial:
- • 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).
...See full criteria on ClinicalTrials.gov
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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.
Treatments Being Tested
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.
Locations (20)
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