Colorectal Cancer Screening for Cancer Survivors

Colorectal Cancer Clinical Trial

Official title:

Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00982059
• Other study ID #: UHN REB 07-0708-CE
• Status: Completed
• Phase: N/A
• First received: November 21, 2008
• Last updated: January 30, 2018
• Start date: May 2008
• Est. completion date: January 24, 2018

Study information

• Verified date: January 2018
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: January 24, 2018
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 49 Years

Eligibility

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.

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Princess Margaret Hospital, Canada

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The proportion of screened patients with any polyp or any high risk polyp will be calculated.		3 years
Secondary	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		3 years