Colorectal Cancer Screening for Cancer Survivors

NCT ID: NCT00982059

Last Updated: 2018-01-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 140 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2018-01-24

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.

Conditions

Colorectal Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

All

All patients enrolled in the study will be undergoing the same procedures.

Colonoscopic examination

Intervention Type: OTHER

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

Interventions

Colonoscopic examination

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Princess Margaret Hospital, Canada

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Hodgson, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Princess Margaret Hospital

Andrea K Ng, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

University Health Network

Toronto, Ontario, Canada

Countries

United States; Canada

References

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.

Reference Type: DERIVED

PMID: 27411369 (View on PubMed)

Other Identifiers

UHN REB 07-0708-CE

Identifier Type: -

Identifier Source: org_study_id