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
  Purpose

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 Intervention
Colorectal Cancer
Other: Colonoscopic examination

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy

Resource links provided by NLM:


Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 140
Study Start Date: May 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   35 Years to 49 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00982059

Locations
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
Investigators
Principal Investigator: David Hodgson, MD University Health Network, Princess Margaret Hospital
Principal Investigator: Andrea K Ng, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT00982059     History of Changes
Other Study ID Numbers: UHN REB 07-0708-CE
Study First Received: November 21, 2008
Last Updated: May 8, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
Colorectal cancer screening
Cancer survivor
Radiation therapy
Cancer Survivor

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Diseases
Gastrointestinal Neoplasms
Intestinal Diseases
Intestinal Neoplasms
Neoplasms
Neoplasms by Site
Rectal Diseases

ClinicalTrials.gov processed this record on October 29, 2014