Colorectal Cancer Screening for Cancer Survivors

Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer
• Intervention / Treatment: Other: Colonoscopic examination

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.

• Study Type: Observational
• Enrollment (Anticipated): 140

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • University Health Network
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who have received radiation treatment to the abdomen,pelvis or spine.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
All; All patients enrolled in the study will be undergoing the same procedures.	Other: Colonoscopic examination; All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The proportion of screened patients with any polyp or any high risk polyp will be calculated.	3 years

Secondary Outcome Measures

Outcome Measure	Time 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 fields	3 years

Collaborators and Investigators

• Sponsor: University Health Network, Toronto
• Collaborators: Princess Margaret Hospital, Canada
• Investigators: Principal Investigator: David Hodgson, MD, University Health Network, Princess Margaret Hospital; Principal Investigator: Andrea K Ng, MD, Dana-Farber Cancer Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): January 24, 2018

Study Registration Dates

• First Submitted: November 21, 2008
• First Submitted That Met QC Criteria: September 21, 2009
• First Posted (Estimate): September 22, 2009

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 30, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Keywords: Cancer survivor; Radiation therapy; Colorectal cancer screening
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: UHN REB 07-0708-CE