Cancer Clinical Trial
Official title:
Pharmacogenetic DNA Bank
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.
| Status | Recruiting |
| Enrollment | 5000 |
| Est. completion date | December 2015 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Any cancer patient who is aged >=18 is eligible. Exclusion Criteria: - Cancer patients who are below age 18 will be excluded. |
Observational Model: Case-Crossover, Time Perspective: Cross-Sectional
| Country | Name | City | State |
|---|---|---|---|
| Singapore | National University Hospital | Singapore |
| Lead Sponsor | Collaborator |
|---|---|
| National University Hospital, Singapore |
Singapore,
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. Epub 2006 Nov 18. — View Citation
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. — View Citation
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