CancerNCT00941200
Pharmacogenetic DNA Bank
An observational study of Cancer, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
Aims of Research Proposal: 1. To build a DNA bank in association with a comprehensive database of treatment outcomes and toxicities of cancer patients. 2. To carry out genotyping of potential candidate genes in relation to specific anti-cancer agents and to correlate genotype with treatment outcomes and toxicities. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Blood collection
- How many people
- 5,000 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2009to Dec 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any individual who has been diagnosed with cancer is eligible.
Who may be able to join
- Any cancer patient who is aged >=18 is eligible.
Who cannot join
- Cancer patients who are below age 18 will be excluded.
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
National University Hospital
Singapore, Singapore, 119074
Soo Chin Lee, MBBS, MRCP, 65 6772 4629, Soo_Chin_Lee@nuhs.edu.sg
Soo Chin Lee, MBBS, MRCP
About this study
Aims of Research Proposal:
- To build a DNA bank in association with a comprehensive database of treatment outcomes and toxicities of cancer patients.
- To carry out genotyping of potential candidate genes in relation to specific anti-cancer agents and to correlate genotype with treatment outcomes and toxicities.
The investigators hypothesize that genetic variations between different individuals and ethnic groups may account for inter-individual and inter-ethnic differences in treatment response and toxicities to anti-cancer therapy. The understanding of the contribution of these genetic variations may help to individualize therapy to optimize treatment outcomes and reduce toxicities. Patients will be recruited from the National University Hospital Cancer Centre. Any individual aged 18 or above who has been diagnosed with cancer is eligible. 20 ml of blood will be collected from each subject for DNA extraction and pharmacogenetics analysis. At the time of recruitment, demographic characteristics, cancer history, and past and present cancer treatment history of the study subject will be collected. The patients' progress will be followed up periodically (approximately every 6 months) through the medical records, and subsequent cancer treatments, progression of cancer, and survival outcome will be updated. Follow-up will occur until death. Important treatment information that will be collected include the drug regimen, drug doses, intent of treatment, aematologic and non-haematologic toxicities, and hospitalization episodes that may be related to treatment. Known functional single nucleotide polymorphisms (SNPs) of drug metabolizing enzymes, transporters and targets of different anti-cancer agents will be characterized. More comprehensive genotyping will be carried out in 'outliers' who experience exceptional toxicity or biological response to identify novel functional SNPs using high throughput sequencing techniques. Correlation will be made between genotype and treatment-related outcomes (tumor response, progression-free survival) and toxicities. For selected patients, lymphoblastoid transformation will be carried out to maintain an infinite supply of DNA.
- 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (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
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 5,000 participants
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Investigators
- Soo Chin Lee, MBBS, MRCP, Principal investigator, National University Hospital, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941200
- Sponsor's protocol ID
- PG01/02/09
- Status last verified
- Jan 2014
- First submitted
- 16 Jul 2009
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wei X, McLeod HL, McMurrough J, Gonzalez FJ, Fernandez-Salguero P. Molecular basis of the human dihydropyrimidine dehydrogenase deficiency and 5-fluorouracil toxicity. J Clin Invest. 1996 Aug 1;98(3):610-5. doi: 10.1172/JCI118830.
PubMed 8698850Goetz MP, Knox SK, Suman VJ, Rae JM, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Weinshilboum RM, Fritcher EG, Nibbe AM, Desta Z, Nguyen A, Flockhart DA, Perez EA, Ingle JN. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat. 2007 Jan;101(1):113-21. doi: 10.1007/s10549-006-9428-0. Epub 2006 Nov 18.
PubMed 17115111
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacogenetic DNA Bank
- ClinicalTrials.gov ID
- NCT00941200
- Acronym / sponsor ID
- PG01/02/09
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 17 Jul 2009 (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.
Aims of Research Proposal:
- To build a DNA bank in association with a comprehensive database of treatment outcomes and toxicities of cancer patients.
- To carry out genotyping of potential candidate genes in relation to specific anti-cancer agents and to correlate genotype with treatment outcomes and toxicities.
The investigators hypothesize that genetic variations between different individuals and ethnic groups may account for inter-individual and inter-ethnic differences in treatment response and toxicities to anti-cancer therapy. The understanding of the contribution of these genetic variations may help to individualize therapy to optimize treatment outcomes and reduce toxicities. Patients will be recruited from the National University Hospital Cancer Centre. Any individual aged 18 or above who has been diagnosed with cancer is eligible. 20 ml of blood will be collected from each subject for DNA extraction and pharmacogenetics analysis. At the time of recruitment, demographic characteristics, cancer history, and past and present cancer treatment history of the study subject will be collected. The patients' progress will be followed up periodically (approximately every 6 months) through the medical records, and subsequent cancer treatments, progression of cancer, and survival outcome will be updated. Follow-up will occur until death. Important treatment information that will be collected include the drug regimen, drug doses, intent of treatment, aematologic and non-haematologic toxicities, and hospitalization episodes that may be related to treatment. Known functional single nucleotide polymorphisms (SNPs) of drug metabolizing enzymes, transporters and targets of different anti-cancer agents will be characterized. More comprehensive genotyping will be carried out in 'outliers' who experience exceptional toxicity or biological response to identify novel functional SNPs using high throughput sequencing techniques. Correlation will be made between genotype and treatment-related outcomes (tumor response, progression-free survival) and toxicities. For selected patients, lymphoblastoid transformation will be carried out to maintain an infinite supply of DNA.
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blood collection | – | Biological: Blood collection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual who has been diagnosed with cancer is eligible.
Key inclusion criteria (1 listed)
- Any cancer patient who is aged >=18 is eligible.
Key exclusion criteria (1 listed)
- Cancer patients who are below age 18 will be excluded.
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2014.
- Background: PubMed 8698850Wei X, McLeod HL, McMurrough J, Gonzalez FJ, Fernandez-Salguero P. Molecular basis of the human dihydropyrimidine dehydrogenase deficiency and 5-fluorouracil toxicity. J Clin Invest. 1996 Aug 1;98(3):610-5. doi: 10.1172/JCI118830.
- Background: PubMed 17115111Goetz MP, Knox SK, Suman VJ, Rae JM, Safgren SL, Ames MM, Visscher DW, Reynolds C, Couch FJ, Lingle WL, Weinshilboum RM, Fritcher EG, Nibbe AM, Desta Z, Nguyen A, Flockhart DA, Perez EA, Ingle JN. The impact of cytochrome P450 2D6 metabolism in women receiving adjuvant tamoxifen. Breast Cancer Res Treat. 2007 Jan;101(1):113-21. doi: 10.1007/s10549-006-9428-0. Epub 2006 Nov 18.
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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.
Soo Chin Lee, MBBS, MRCP principal investigator
National University Hospital, Singapore
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 1 inclusion and 1 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 14 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00941200, 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 14 Jan 2014.