Cancer Clinical Trial - Pharmacogenetic DNA Bank

Status Recruiting

Clinical 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.

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.

Clinical Trial Description

n/a

Study Design

Observational Model: Case-Crossover, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Cancer

Clinical Trial Details

NCT number	NCT00941200
Study type	Observational
Source	National University Hospital, Singapore
Contact	Soo Chin Lee, MBBS, MRCP
Phone	65 6772 4629
Email	Soo_Chin_Lee@nuhs.edu.sg
Status	Recruiting
Phase	N/A
Start date	April 2009
Completion date	December 2015

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.