Pharmacogenetic DNA Bank

This study is currently recruiting participants.
Verified January 2014 by National University Hospital, Singapore
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00941200
First received: July 16, 2009
Last updated: January 13, 2014
Last verified: January 2014

July 16, 2009
January 13, 2014
April 2009
December 2015   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00941200 on ClinicalTrials.gov Archive Site
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Pharmacogenetic DNA Bank
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.

Not Provided
Observational
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
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Retention:   Samples With DNA
Description:

Blood sample

Non-Probability Sample

Any individual who has been diagnosed with cancer is eligible.

Cancer
Biological: Blood collection
Blood collection
Intervention: Biological: Blood collection

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
5000
December 2015
December 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Any cancer patient who is aged >=18 is eligible.

Exclusion Criteria:

  • Cancer patients who are below age 18 will be excluded.
Both
18 Years and older
No
Contact: Soo Chin Lee, MBBS, MRCP 65 6772 4629 Soo_Chin_Lee@nuhs.edu.sg
Singapore
 
NCT00941200
PG01/02/09
No
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National University Hospital, Singapore
Not Provided
Principal Investigator: Soo Chin Lee, MBBS, MRCP National University Hospital, Singapore
National University Hospital, Singapore
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP