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OpenTrials
Completed

NCT Number: NCT00982059

Colorectal Cancer Screening for Cancer Survivors

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

35 year–49 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Health Network, Toronto, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Colonoscopic examination

Other

All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.

Primary outcomes

  1. The proportion of screened patients with any polyp or any high risk polyp will be calculated.

    Time frame: 3 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • Princess Margaret Hospital, Canada

Registry information

Official study title

Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy

Important dates

Study start
2008
Primary completion
2014
Study completion
2018
First posted
Sep 22, 2009
Registry last updated
Jan 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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