Clinical trial NCT00982059: Colorectal Cancer Screening for Cancer Survivors
Official title: Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Keywords: Colorectal cancer screening
Cancer survivor
Radiation therapy
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Princess Margaret Hospital, Canada
First posted: 2009-09-22
Enrollment: 140
Sex: ALL
Minimum age (years): 35
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have received radiation treatment to the abdomen,pelvis or spine.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The proportion of screened patients with any polyp or any high risk polyp will be calculated.
timeFrame: 3 years
Secondary outcomes:
measure: 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
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Princess Margaret Hospital
name: David Hodgson, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Andrea K Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Daly PE, Samiee S, Cino M, Gryfe R, Pollett A, Ng A, Constine LS, Hodgson DC. High prevalence of adenomatous colorectal polyps in young cancer survivors treated with abdominal radiation therapy: results of a prospective trial. Gut. 2017 Oct;66(10):1797-1801. doi: 10.1136/gutjnl-2016-311501. Epub 2016 Jul 13.