CancerNCT01050920
Study of Genetic Factors Other Than CYP2C9 and VKORC1 That Influence Warfarin Dose Requirements in a South-east Asian Population
An observational study of Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide inter-individual and inter-ethnic variation in dose requirements. Several genetic and non-genetic factors have been identified that could influence warfarin dose requirements. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood collection
- How many people
- Not given
- Where
- 1 siteSingapore
- Study dates
- Sep 2013to Dec 2014
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Germline DNA will be genotyped for variants in genes in the anti-coagulation pathway, including CYP4F2, GGCX and EPHX1. The germline DNA was previously collected from a warfarin study (C/00/510, NUH, C/00/535, TTSH, PI-Dr Goh Boon Cher). Samples were anonymized, and data analysis will be done without patient identifiers. Germline DNA previously collected from 279 patients who were on maintenance warfarin dose will be genotyped. The clinical data that has been collected and will be used for the study include: gender, race, age, body weight, maintenance warfarin dose, serum albumin, two consecutive stable INR values, and indications for warfarin use.
Who may be able to join
- patients receiving maintenance warfarin therapy with a stable therapeutic international normalized ratio (INR) between 2 and 3 for at least 3 months,
- patients recruited from the anticoagulation clinics at the National University Hospital and Tan Tock Seng Hospital in Singapore between June 2002 and June 2004 for a previous genotyping study (C/00/510, NUH; C/00/535, TTSH, PI-Dr Goh Boon Cher).
Who cannot join
- patients below 21 years old, or
- patients with liver disease, malabsorption or chronic diarrheal diseases, or
- patients taking drugs that may potentially interact with warfarin.
- Dietary advice to avoid foods that may interfere with warfarin pharmacokinetics will be given to patients during warfarin therapy.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, 119074
Soo Chin Lee, MBBS, MRCP, 65 6772 4629, soo_chin_lee@nuhs.edu.sg
About this study
Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide inter-individual and inter-ethnic variation in dose requirements. Several genetic and non-genetic factors have been identified that could influence warfarin dose requirements. However, current known predictive factors could only explain about 50-60% of warfarin dose variability. Inter-ethnic differences in genetic influences on warfarin dose requirements also exist. We hypothesize that genetic factors other than CYP2C9 and VKORC1 may influence warfarin dosing and serve to further optimize warfarin dosing.
- Conditions
- Cancer
- Being tested
- Blood collection
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood collectionBiological
| Study group | Role | What they receive |
|---|---|---|
| Blood Collection | Not described Receives: Biological: Blood collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify genetic variants other than CYP2C9 and VKORC1 that may influence warfarin dose requirements in a multi-ethnic population in Singapore.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2010 (estimated)
- Study startSep 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Cohort
- Time perspective
- Cross-sectional
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01050920
- Sponsor's protocol ID
- PK03/32/09
- Status last verified
- Jan 2014
- First submitted
- 15 Jan 2010
- Last updated
- 22 Jan 2014
- Results posted
- No
Publications
Hirsh J, Fuster V, Ansell J, Halperin JL; American Heart Association/American College of Cardiology Foundation. American Heart Association/American College of Cardiology Foundation guide to warfarin therapy. J Am Coll Cardiol. 2003 May 7;41(9):1633-52. doi: 10.1016/s0735-1097(03)00416-9. No abstract available.
PubMed 12742309Poller L, Taberner DA. Dosage and control of oral anticoagulants: an international collaborative survey. Br J Haematol. 1982 Jul;51(3):479-85. doi: 10.1111/j.1365-2141.1982.tb02805.x.
PubMed 7104231
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Genetic Factors Other Than CYP2C9 and VKORC1 That Influence Warfarin Dose Requirements in a South-east Asian Population
- ClinicalTrials.gov ID
- NCT01050920
- Acronym / sponsor ID
- PK03/32/09
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 18 Jan 2010 (estimated)
- 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.
Warfarin is a commonly used anti-coagulant, but has a narrow therapeutic index and wide inter-individual and inter-ethnic variation in dose requirements. Several genetic and non-genetic factors have been identified that could influence warfarin dose requirements. However, current known predictive factors could only explain about 50-60% of warfarin dose variability. Inter-ethnic differences in genetic influences on warfarin dose requirements also exist. We hypothesize that genetic factors other than CYP2C9 and VKORC1 may influence warfarin dosing and serve to further optimize warfarin dosing.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood Collection | – | Biological: Blood collection |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Germline DNA will be genotyped for variants in genes in the anti-coagulation pathway, including CYP4F2, GGCX and EPHX1. The germline DNA was previously collected from a warfarin study (C/00/510, NUH, C/00/535, TTSH, PI-Dr Goh Boon Cher). Samples were anonymized, and data analysis will be done without patient identifiers. Germline DNA previously collected from 279 patients who were on maintenance warfarin dose will be genotyped. The clinical data that has been collected and will be used for the study include: gender, race, age, body weight, maintenance warfarin dose, serum albumin, two consecutive stable INR values, and indications for warfarin use.
Key inclusion criteria (2 listed)
- patients receiving maintenance warfarin therapy with a stable therapeutic international normalized ratio (INR) between 2 and 3 for at least 3 months,
- patients recruited from the anticoagulation clinics at the National University Hospital and Tan Tock Seng Hospital in Singapore between June 2002 and June 2004 for a previous genotyping study (C/00/510, NUH; C/00/535, TTSH, PI-Dr Goh Boon Cher).
Key exclusion criteria (4 listed)
- patients below 21 years old, or
- patients with liver disease, malabsorption or chronic diarrheal diseases, or
- patients taking drugs that may potentially interact with warfarin.
- Dietary advice to avoid foods that may interfere with warfarin pharmacokinetics will be given to patients during warfarin therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood collection | Biological | Blood Collection |
Primary outcome
To identify genetic variants other than CYP2C9 and VKORC1 that may influence warfarin dose requirements in a multi-ethnic population in Singapore.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
- Background: PubMed 12742309Hirsh J, Fuster V, Ansell J, Halperin JL; American Heart Association/American College of Cardiology Foundation. American Heart Association/American College of Cardiology Foundation guide to warfarin therapy. J Am Coll Cardiol. 2003 May 7;41(9):1633-52. doi: 10.1016/s0735-1097(03)00416-9. No abstract available.
- Background: PubMed 7104231Poller L, Taberner DA. Dosage and control of oral anticoagulants: an international collaborative survey. Br J Haematol. 1982 Jul;51(3):479-85. doi: 10.1111/j.1365-2141.1982.tb02805.x.
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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.
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 Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
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 2 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: status not confirmed, as of the sponsor's last update on 22 Jan 2014. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Soo Chin Lee, MBBS, MRCP (65 6772 4629, soo_chin_lee@nuhs.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify genetic variants other than CYP2C9 and VKORC1 that may influence warfarin dose requirements in a multi-ethnic population in Singapore.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01050920, which also lists 2 linked publications.
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 22 Jan 2014.