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

Description

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.

Conditions

Adenocarcinoma of the Colon, Adenocarcinoma of the Rectum

Study Overview

Study Details

Study overview

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.

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

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

Condition
Adenocarcinoma of the Colon
Intervention / Treatment

-

Contacts and Locations

Phoenix

Cancer Center at Saint Joseph's, Phoenix, Arizona, United States, 85004

Hot Springs

CHI Saint Vincent Cancer Center Hot Springs, Hot Springs, Arkansas, United States, 71913

Arroyo Grande

Mission Hope Medical Oncology - Arroyo Grande, Arroyo Grande, California, United States, 93420

Dublin

Epic Care-Dublin, Dublin, California, United States, 94568

Emeryville

Bay Area Breast Surgeons Inc, Emeryville, California, United States, 94608

Emeryville

Epic Care Partners in Cancer Care, Emeryville, California, United States, 94608

Los Angeles

UCLA / Jonsson Comprehensive Cancer Center, Los Angeles, California, United States, 90095

Martinez

Contra Costa Regional Medical Center, Martinez, California, United States, 94553-3156

Oakland

Alta Bates Summit Medical Center - Summit Campus, Oakland, California, United States, 94609

Oakland

Bay Area Tumor Institute, Oakland, California, United States, 94609

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.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * • The participant must have signed and dated an IRB-approved consent form that conforms to federal and institutional guidelines.
  • * 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.
  • * • 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 greater 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.

Ages Eligible for Study

50 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

NRG Oncology,

Robert Schoen, MD, STUDY_CHAIR, University of Pittsburgh

Study Record Dates

2065-11-01