Colorectal Cancer Screening for Cancer Survivors
This trial is active, not recruiting.
|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.
All patients enrolled in the study will be undergoing the same procedures.
The proportion of screened patients with any polyp or any high risk polyp will be calculated.
time frame: 3 years
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
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.
|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.|
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