Colorectal NeoplasmsNCT03155542
Alcohol Intake, Alcohol Metabolizing Enzymes Gene Polymorphisms and the Risk of Colorectal Cancer
An observational study of Colorectal Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colorectal Neoplasms
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2016to 29 Mar 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: primary care clinic visit at National Taiwan University Hospital
Who may be able to join
- 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
Who cannot join
- History of familial adenomatous polyposis
- History of partial or total removal of the colorectum
- History of inflammatory bowl disease
- History of malignant neoplasms
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Colorectal Neoplasms
- Keywords
- alcohol, gene polymorphisms, Colorectal cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
colorectal cancer diagnosis
Histologically confirmed colorectal adenocarcinoma
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2017
- Study startDec 2016
- Primary completion22 Mar 2017
- Study completion29 Mar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yen-Hui CHEN, Principal investigator, Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03155542
- Sponsor's protocol ID
- 201610059RIND
- Status last verified
- May 2017
- First submitted
- 14 May 2017
- Last updated
- 23 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alcohol Intake, Alcohol Metabolizing Enzymes Gene Polymorphisms and the Risk of Colorectal Cancer
- ClinicalTrials.gov ID
- NCT03155542
- Acronym / sponsor ID
- 201610059RIND
- Conditions
- Colorectal Neoplasms
- Keywords
- alcohol, gene polymorphisms, Colorectal cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- 22 Mar 2017 (actual)
- Study completion
- 29 Mar 2017 (actual)
- First posted
- 16 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- primary care clinic visit at National Taiwan University Hospital
Key inclusion criteria (7 listed)
- Histologically confirmed colorectal adenocarcinoma at National Taiwan University Hospital (NTUH) from 2000 to 2016
- Age >20 at the time of inclusion
- 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
Key exclusion criteria (4 listed)
- History of familial adenomatous polyposis
- History of partial or total removal of the colorectum
- History of inflammatory bowl disease
- History of malignant neoplasms
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
colorectal cancer diagnosis
Time frame: 4 months
Histologically confirmed colorectal adenocarcinoma
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yen-Hui CHEN principal investigator
Graduate Institute of Clinical Pharmacy, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Neoplasms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
colorectal cancer diagnosis (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2017.