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NCT00716287 Clinical Trial

Characterisation of Gene Variants in the Angiogenic Pathway

Solid Tumors Clinical Trial

Official title:
Characterisation of Gene Variants in the Angiogenic Pathway

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT00716287
Other study ID # MC01/03/07
Secondary ID
Status Active, not recruiting
Phase N/A
First received July 15, 2008
Last updated January 13, 2014
Start date March 2007

Study information
Verified date January 2014
Source National University Hospital, Singapore
Contact n/a
Is FDA regulated No
Health authority Singapore: Domain Specific Review Board
Study type Observational

Clinical Trial Summary

Anti-angiogenic targeted therapies are used in a wide range of solid tumors including NSCLC, breast cancer, GISTs, CRC, renal cell carcinoma and hepatocellular carcinoma. Somatic mutations in genes related to tumorigenesis have been associated with treatment response whereas germline gene variants have been associated with tumor risk, prognosis and treatment related toxicity.Study objectives are:

1. To characterise the prevalence and clinicopathological associations of germline and somatic variation in genes involved in the angiogenic pathway in healthy donors and unselected cancer patients

2. To examine the association between angiogenic gene variants and outcome in patients receiving anti-angiogenic therapy

Description:

Angiogenesis plays a key role in the process of tumour growth and metastases. Anti-angiogenic targeted therapies are currently used in a wide range of solid tumors including lung, breast, colorectal, kidney and liver cancer. Somatic variants in genes related to tumorigenesis have been associated with treatment response, whereas germline gene variants have been associated with tumor risk, prognosis and treatment related toxicity. In this study we propose to (1) To characterise the prevalence and clinicopathological associations of germline and somatic variation in genes involved in the angiogenic pathway in healthy donors and unselected cancer patients (2) to examine the association between angiogenic gene variants and outcome in patients receiving anti-angiogenic therapy. Genes related to angiogenesis to be characterised include those encoding platelet derived growth factor receptors, vascular endothelial growth factors, vascular endothelial growth factor receptors, K-Ras, B-Raf, and c-kit. Results from this study may (1) identify patients who are more likely to respond to anti-angiogenic targeted therapy, thus maximising drug efficacy and (2) to identify further targets for potential anti-angiogenic drug therapies.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 0
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Anti-angiogenic targeted therapies are used in a wide range of solid tumors including NSCLC, breast cancer, GISTs, CRC, renal cell carcinoma and hepatocellular carcinoma

Study Design

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

Related Conditions & MeSH terms

Locations
Country Name City State
Singapore National University Hospital Singapore

Sponsors (1)
Lead Sponsor Collaborator
National University Hospital, Singapore

Country where clinical trial is conducted

Singapore, 

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