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Colorectal Cancer Screening for Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Princess Margaret Hospital, Canada
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00982059
First received: November 21, 2008
Last updated: May 8, 2014
Last verified: May 2014

November 21, 2008
May 8, 2014
May 2008
December 2014   (final data collection date for primary outcome measure)
The proportion of screened patients with any polyp or any high risk polyp will be calculated. [ Time Frame: 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00982059 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Retrospective
Not Provided
Not Provided
Non-Probability Sample

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

Colorectal Cancer
Other: Colonoscopic examination
All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.
All
All patients enrolled in the study will be undergoing the same procedures.
Intervention: Other: Colonoscopic examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
140
December 2014
December 2014   (final data collection date for primary outcome measure)

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.
Both
35 Years to 49 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00982059
UHN REB 07-0708-CE
Yes
University Health Network, Toronto
University Health Network, Toronto
Princess Margaret Hospital, Canada
Principal Investigator: David Hodgson, MD University Health Network, Princess Margaret Hospital
Principal Investigator: Andrea K Ng, MD Dana-Farber Cancer Institute
University Health Network, Toronto
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP