Colorectal Cancer Screening for Cancer Survivors
This study is currently recruiting participants.
Verified December 2012 by University Health Network, Toronto
Sponsor:
University Health Network, Toronto
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: December 20, 2012
Last verified: December 2012
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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: | March 2014 |
| Estimated Primary Completion Date: | March 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:
- Asymptomatic survivors treated with ≥ 25Gy to the abdomen, pelvis or spine, or ≥ 12Gy total body radiation therapy, or ≥ 12Gy whole abdominal RT.
- Patients who have passed ≥10 years following RT
- Patients whose current age is 35-49.
Exclusion Criteria:
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
- Patients with a history of Crohn's disease or ulcerative colitis
- Patients already taking part in a colorectal screening program defined as any colorectal screening (colonoscopy, sigmoidoscopy, fecal occult blood test) within last 5 years.
- Patients with self-reported history of colorectal polyps.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00982059
Contacts
| Contact: David Hodgson, MD | 416 946 2919 | david.hodgson@rmp.uhn.on.ca |
Locations
| United States, Massachusetts | |
| Dana-Farber Cancer Institute | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Andrea K Ng, MD 617-732-6310 | |
| Principal Investigator: Andrea K Ng, MD | |
| Canada, Ontario | |
| University Health Network | Recruiting |
| Toronto, Ontario, Canada, M5G 2M9 | |
| Contact: David Hodgson, MD 416 946 2919 david.hodgson@rmp.uhn.on.ca | |
| Principal Investigator: David Hodgson, MD | |
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: | December 20, 2012 |
| 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 Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms |
Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013