Colorectal CancerNCT00982059
Colorectal Cancer Screening for Cancer Survivors
An observational study of Colorectal Cancer, run by University Health Network, Toronto at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 49 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Colonoscopic examination
- How many people
- 140 participants
- Where
- 2 sitesin 2 countries
- Study dates
- May 2008to 24 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 49 years
- All sexes
- No healthy volunteers
- Adult
Study population: Patients who have received radiation treatment to the abdomen,pelvis or spine.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
United States1 site
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
About this study
Official title: 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.
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Colonoscopic examination
- Keywords
- Colorectal cancer screening, Cancer survivor, Radiation therapy
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colonoscopic examinationOther
All patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire.
| Study group | Role | What they receive |
|---|---|---|
| All | All patients enrolled in the study will be undergoing the same procedures. Receives: Other: Colonoscopic examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of screened patients with any polyp or any high risk polyp will be calculated.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2009 (estimated)
- Study startMay 2008
- Primary completionDec 2014
- Study completion24 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Responsible party
- Sponsor
- Investigators
- David Hodgson, MD, Principal investigator, University Health Network, Princess Margaret HospitalAndrea K Ng, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00982059
- Sponsor's protocol ID
- UHN REB 07-0708-CE
- Status last verified
- Jan 2018
- First submitted
- 21 Nov 2008
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27411369
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening in Cancer Survivors Treated With Radiation Therapy
- ClinicalTrials.gov ID
- NCT00982059
- Acronym / sponsor ID
- UHN REB 07-0708-CE
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer screening, Cancer survivor, Radiation therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada
- Study start
- May 2008
- Primary completion
- Dec 2014 (actual)
- Study completion
- 24 Jan 2018 (actual)
- First posted
- 22 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | Other: Colonoscopic examinationAll patients enrolled in the study will be undergoing the same procedures. |
Who may qualify
- Ages
- 35 to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Patients who have received radiation treatment to the abdomen,pelvis or spine.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- Patients with signs/symptoms suggestive of CRC or other high-risk features such as:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colonoscopic examinationAll patients enrolled in the study will undergo a colonoscopic examination and complete a baseline questionnaire. | Other | All |
Primary outcome
The proportion of screened patients with any polyp or any high risk polyp will be calculated.
Time frame: 3 years
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2018.
- Derived from this study: PubMed 27411369Daly 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Hodgson, MD principal investigator
University Health Network, Princess Margaret Hospital
Andrea K Ng, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by University Health Network, Toronto at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of screened patients with any polyp or any high risk polyp will be calculated. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00982059, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2018.