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

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
      • Taipei, ROC, Taiwan
        • National Taiwan University Hospital

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
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

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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