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Colorectal Cancer Screening for Cancer Survivors

Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00982059
Enrollment
140
Registered
2009-09-22
Start date
2008-05-31
Completion date
2018-01-24
Last updated
2018-01-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screening, Cancer survivor, Radiation therapy

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.

Interventions

All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.

Sponsors

Princess Margaret Hospital, Canada
CollaboratorOTHER
University Health Network, Toronto
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
35 Years to 49 Years
Healthy volunteers
No

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.

Design outcomes

Primary

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

Secondary

MeasureTime frame
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 fields3 years

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026