- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03155542
Alcohol Intake, Alcohol Metabolizing Enzymes Gene Polymorphisms and the Risk of Colorectal Cancer
May 21, 2017 updated by: National Taiwan University Hospital
According to the statistic reports from World Health Organization (WHO) International Agency for Research on Cancer (IARC), the incidence and mortality rate of colorectal cancer ranked third and fourth respectively among ten most commonly diagnosed cancer worldwide; moreover, based on the statistics from Health Promotion Administration, Ministry of Health and Welfare in Taiwan, the incidence and mortality rate of colorectal cancer ranked second and third respectively among call cancer in Taiwanese population.
However, if colorectal cancer is diagnosed and treated in early phase, the 5-year survival rate for stage I colorectal cancer can be up to 90%; on the other hand, the 5-year survival rate for end stage colorectal cancer is only approximately 10%.
Therefore, the screening, early diagnosis od colorectal cancer is crucial.
To date, there are some known risk factors for colorectal cancer, including familial adenomatous polyposis, obesity, physical inactivity, etc. Alcohol had also been identified as an important risk factor for colorectal cancer, and the risk could be higher among Asian population because of the reduced enzymatic activity of some of the alcohol metabolizing enzymes.
Thus, through this study, the investigators hope to find out the risk factors of colorectal cancer among Taiwanese population, including alcohol metabolizing enzyme gene polymorphisms and their interaction with environmental factors, to attain the purpose of early prevention of colorectal cancer.
Study Overview
Status
Completed
Conditions
Detailed Description
The purpose of this study is to find out relationship between alcohol metabolizing enzyme gene polymorphism and colorectal cancer, and discuss the impact of the interaction between gene polymorphism and environmental factors on the risk of colorectal cancer.
Study Type
Observational
Enrollment (Actual)
140
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
-
-
ROC
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Taipei, ROC, Taiwan
- National Taiwan University 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
20 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
primary care clinic visit at National Taiwan University Hospital
Description
Inclusion criteria:
Case:
- Histologically confirmed colorectal adenocarcinoma at National Taiwan University Hospital (NTUH) from 2000 to 2016
- Age >20 at the time of inclusion
Control:
- No diagnosis of colorectal cancer
- Age >20 at the time of inclusion
- Family members of case, including parents, siblings, offspring, spouse mother-in-law or daughter-in-law
Exclusion criteria (Both for case and control):
- History of familial adenomatous polyposis
- History of partial or total removal of the colorectum
- History of inflammatory bowl disease
- History of malignant neoplasms
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 |
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colorectal cancer patient case group
Histologically confirmed colorectal adenocarcinoma
|
family member control group
without the diagnosis of CRC and accompanied the patient to the primary care clinic visit
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
colorectal cancer diagnosis
Time Frame: 4 months
|
Histologically confirmed colorectal adenocarcinoma
|
4 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yen-Hui CHEN, Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University
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 (Actual)
December 1, 2016
Primary Completion (Actual)
March 22, 2017
Study Completion (Actual)
March 29, 2017
Study Registration Dates
First Submitted
May 14, 2017
First Submitted That Met QC Criteria
May 15, 2017
First Posted (Actual)
May 16, 2017
Study Record Updates
Last Update Posted (Actual)
May 23, 2017
Last Update Submitted That Met QC Criteria
May 21, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201610059RIND
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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