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Colorectal Cancer Screening for Cancer Survivors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00982059
Recruitment Status : Completed
First Posted : September 22, 2009
Last Update Posted : January 31, 2018
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto

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.

Condition or disease Intervention/treatment
Colorectal Cancer 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.

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Study Type : Observational
Estimated Enrollment : 140 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy
Study Start Date : May 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : January 24, 2018

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
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.

Primary Outcome Measures :
  1. The proportion of screened patients with any polyp or any high risk polyp will be calculated. [ Time Frame: 3 years ]

Secondary Outcome Measures :
  1. 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 [ Time Frame: 3 years ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   35 Years to 49 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who have received radiation treatment to the abdomen,pelvis or spine.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00982059

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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Princess Margaret Hospital, Canada
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Principal Investigator: David Hodgson, MD University Health Network, Princess Margaret Hospital
Principal Investigator: Andrea K Ng, MD Dana-Farber Cancer Institute
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: University Health Network, Toronto Identifier: NCT00982059    
Other Study ID Numbers: UHN REB 07-0708-CE
First Posted: September 22, 2009    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018
Keywords provided by University Health Network, Toronto:
Colorectal cancer screening
Cancer survivor
Radiation therapy
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases