Screening for Colorectal Neoplasm in First Degree Relatives of the Affected
April 20, 2017 updated by: James Yun-wong Lau, Chinese University of Hong Kong
Colonoscopic Screening in First-degree Relatives of Hong Kong Chinese Patients With Sporadic Colorectal Cancer: a Cohort Study With Case Control Analysis
To determine the prevalence of colorectal neoplasms in first degree relatives of those affected with sporadic colorectal cancer using colonoscopy as a screening tool.
The prevalence will be compared to that of a defined matched cohort.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Colorectal cancer is a second commonest tumor in Hong Kong and the second commonest cause of cancer related death.
About 1 in 23 males will develop colorectal cancer in his life time.
The disease tends to cluster in families.
This may be a combination of factors including shared genes, shared environment or chance.
Known familial syndromes occur in only about 5% of cases.
The majority is not well understood and labelled sporadic colorectal cancer.
The screening strategy in families of subjects with colorectal cancer has not been defined.
Colonoscopy is among the most sensitive and specific screening tool for colorectal neoplasm.
The current study determines the prevalence of adenomas among first degree relatives of patients diagnosed with colorectal cancer.
To quantify risk in this cohort, a case control analysis is used.
The prevalence of the cohort is compared to that of a control population.
The control group consists of relatives of patients with normal colonoscopic findings during the same study period.
Study Type
Observational
Enrollment (Actual)
748
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong (SAR), China
- Endoscopy Center, Prince of Wales Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
First degree relatives of patients having CRC or patient having normal colonoscopy
Description
Inclusion Criteria:
- First degree relatives (age >40 and <70) of individuals affected with sporadic colorectal cancer (those not associated with inflammatory bowel disease, familial adenomatous polyposis or HNPCC syndrome).
Exclusion Criteria:
- A family history compatible with that of Hereditary Non-polyposis Colon Cancer (HNPCC) based on the Amsterdam criteria [Table 5].
- Known Familial Adenomatous Polyposis (FAP) syndrome
- Patients and relatives with known inflammatory bowel disease
- Relatives that have received colonoscopy examinations in the past 5 years [details of colonoscopic examinations will be sought and information on colonic neoplasms recorded]. Those who have had barium enema examinations are eligible for trial inclusion as barium examinations often have low sensitivity and specificity for adenomas (around 70% respectively)
- Severe cardio-pulmonary or other medical co-morbidities that preclude safe colonoscopic examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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FDR of CRC patient
First degree relatives of patients having CRC
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To determine the adenomas during colonoscopy
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FDR of normal colonoscopy
First degree relatives of patients having normal colonoscopy
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To determine the adenomas during colonoscopy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To find the prevalence of adenomas and advanced neoplasms of the first degree relatives
Time Frame: 7 years
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7 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Primary Completion (ACTUAL)
August 1, 2016
Study Completion (ACTUAL)
April 6, 2017
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 14, 2005
Study Record Updates
Last Update Posted (ACTUAL)
April 21, 2017
Last Update Submitted That Met QC Criteria
April 20, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FDR
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