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Screening for Colorectal Neoplasm in First Degree Relatives of the Affected

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ClinicalTrials.gov Identifier: NCT00164944
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Brief Summary:
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.

Condition or disease Intervention/treatment
Colorectal Cancer Screening Procedure: Colonoscopy

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.

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Study Type : Observational
Actual Enrollment : 748 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Colonoscopic Screening in First-degree Relatives of Hong Kong Chinese Patients With Sporadic Colorectal Cancer: a Cohort Study With Case Control Analysis
Study Start Date : April 2004
Actual Primary Completion Date : August 2016
Actual Study Completion Date : April 6, 2017

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
FDR of CRC patient
First degree relatives of patients having CRC
Procedure: Colonoscopy
To determine the adenomas during colonoscopy

FDR of normal colonoscopy
First degree relatives of patients having normal colonoscopy
Procedure: Colonoscopy
To determine the adenomas during colonoscopy




Primary Outcome Measures :
  1. To find the prevalence of adenomas and advanced neoplasms of the first degree relatives [ Time Frame: 7 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
First degree relatives of patients having CRC or patient having normal colonoscopy
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164944


Locations
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China
Endoscopy Center, Prince of Wales Hospital
Hong Kong (SAR), China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
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Principal Investigator: James Y Lau, MD Prince of Wales Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James Yun-wong Lau, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT00164944    
Other Study ID Numbers: FDR
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 21, 2017
Last Verified: April 2017
Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Colonoscopy
First degree relatives
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases