NCT00982059

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2008

Longer than P75 for all trials

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2008

Completed
10 months until next milestone

First Posted

Study publicly available on registry

September 22, 2009

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2018

Completed
Last Updated

January 31, 2018

Status Verified

January 1, 2018

Enrollment Period

6.6 years

First QC Date

November 21, 2008

Last Update Submit

January 30, 2018

Conditions

Colorectal Cancer

Keywords

Colorectal cancer screeningCancer survivorRadiation therapy

Outcome Measures

Primary Outcomes (1)

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

    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

    3 years

Study Arms (1)

All

All patients enrolled in the study will be undergoing the same procedures.

Other: Colonoscopic examination

Interventions

Colonoscopic examinationOTHER

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

All

Eligibility Criteria

Age35 Years - 49 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dana-Farber Cancer Institute

Boston, Massachusetts, 02115, United States

Location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Location

Related Publications (1)

  • Daly PE, Samiee S, Cino M, Gryfe R, Pollett A, Ng A, Constine LS, Hodgson DC. High prevalence of adenomatous colorectal polyps in young cancer survivors treated with abdominal radiation therapy: results of a prospective trial. Gut. 2017 Oct;66(10):1797-1801. doi: 10.1136/gutjnl-2016-311501. Epub 2016 Jul 13.

    PMID: 27411369DERIVED

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • David Hodgson, MD

    University Health Network, Princess Margaret Hospital

    PRINCIPAL INVESTIGATOR

  • Andrea K Ng, MD

    Dana-Farber Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2008

First Posted

September 22, 2009

Study Start

May 1, 2008

Primary Completion

December 1, 2014

Study Completion

January 24, 2018

Last Updated

January 31, 2018

Record last verified: 2018-01

Locations

CA(1)US(1)