Pharmacogenetic DNA Bank

NCT ID: NCT00941200

Last Updated: 2014-01-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

5000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-04-30

Study Completion Date

2015-12-31

Brief Summary

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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.

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.

Detailed Description

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Conditions

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Cancer

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Blood collection

Blood collection

Intervention Type BIOLOGICAL

Interventions

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Blood collection

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Any cancer patient who is aged \>=18 is eligible.

Exclusion Criteria

* Cancer patients who are below age 18 will be excluded.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Principal Investigators

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Soo Chin Lee, MBBS, MRCP

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, Singapore, Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Soo Chin Lee, MBBS, MRCP

Role: CONTACT

65 6772 4629

Facility Contacts

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Soo Chin Lee, MBBS, MRCP

Role: primary

65 6772 4629

References

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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.

Reference Type BACKGROUND
PMID: 8698850 (View on PubMed)

Goetz 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.

Reference Type BACKGROUND
PMID: 17115111 (View on PubMed)

Other Identifiers

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PG01/02/09

Identifier Type: -

Identifier Source: org_study_id

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