NCT03155542

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
140

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2017

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 16, 2017

Completed
Last Updated

May 23, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

May 14, 2017

Last Update Submit

May 21, 2017

Conditions

Keywords

alcoholgene polymorphismsColorectal cancer

Outcome Measures

Primary Outcomes (1)

  • colorectal cancer diagnosis

    Histologically confirmed colorectal adenocarcinoma

    4 months

Study Arms (2)

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

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

primary care clinic visit at National Taiwan University Hospital

You may qualify if:

  • Case:
  • Histologically confirmed colorectal adenocarcinoma at National Taiwan University Hospital (NTUH) from 2000 to 2016
  • Control:
  • No diagnosis of colorectal cancer
  • Family members of case, including parents, siblings, offspring, spouse mother-in-law or daughter-in-law

You may not qualify if:

  • History of familial adenomatous polyposis
  • History of partial or total removal of the colorectum
  • History of inflammatory bowl disease
  • History of malignant neoplasms

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, ROC, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

5-10 ml venous blood sample

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Yen-Hui CHEN

    Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2017

First Posted

May 16, 2017

Study Start

December 1, 2016

Primary Completion

March 22, 2017

Study Completion

March 29, 2017

Last Updated

May 23, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations