This trial is active, not recruiting.

Condition colorectal cancer
Treatment colonoscopic examination
Sponsor University Health Network, Toronto
Collaborator Princess Margaret Hospital, Canada
Start date May 2008
End date December 2014
Trial size 140 participants
Trial identifier NCT00982059, UHN REB 07-0708-CE


The risk of colorectal cancer (CRC) is significant among cancer survivors treated with abdominal radiation therapy (RT). Further, CRC is once of the few cancers for which there is effective screening. Although some expert groups recommend early CRC screening for patients with prior abdominal RT, the effectiveness of early screening is unknown. It is also unknown if radiation-induced CRC passes through a "pre-clinical" phase in which precancerous polyps are detectable and treatable prior to becoming invasive cancers. This study will evaluate whether screening will detect pre-invasive colorectal polyps among survivors treated with RT.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective retrospective
All patients enrolled in the study will be undergoing the same procedures.
colonoscopic examination
All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.

Primary Outcomes

The proportion of screened patients with any polyp or any high risk polyp will be calculated.
time frame: 3 years

Secondary Outcomes

Proportion calculation/identification of: demographic/treatment influences on polyp prevalence; subgroups w/polyp prevalence >20%; pts with polyps beyond 30cm flexible sigmoidoscope; pts with adenomatous polyp(s) on colonoscopy in/outside prior RT fields
time frame: 3 years

Eligibility Criteria

Male or female participants from 35 years up to 49 years old.

Inclusion Criteria: 1. Asymptomatic survivors treated with ≥ 25Gy to the abdomen, pelvis or spine, or ≥ 12Gy total body radiation therapy, or ≥ 12Gy whole abdominal RT. 2. Patients who have passed ≥10 years following RT 3. Patients whose current age is 35-49. Exclusion Criteria: 1. Patients with signs/symptoms suggestive of CRC or other high-risk features such as: - Persistent constipation for >2 weeks in the last month - One or more unexplained episodes of red blood in the stool in the last month - One or more unexplained episodes of black stool in the last month - Unexplained pelvic pain in the last month 2. Patients with a history of Crohn's disease or ulcerative colitis 3. Patients already taking part in a colorectal screening program defined as any colorectal screening (colonoscopy, sigmoidoscopy, fecal occult blood test) within last 5 years. 4. Patients with self-reported history of colorectal polyps.

Additional Information

Official title Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy
Principal investigator David Hodgson, MD
Description Cancer survivors meeting the COG criteria for CRC screening will undergo colonoscopy and removal of colorectal polyps. Documentation of polyp number, location and pathologic characteristics will be made. Clinical data information will also be collected at the time of patient enrollment.
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Health Network, Toronto.