Characterisation of Gene Variants in the Angiogenic Pathway

NCT ID: NCT00716287

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

Study Classification

OBSERVATIONAL

Study Start Date

2007-03-31

Brief Summary

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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

Detailed Description

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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.

Conditions

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Solid Tumors

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National University Hospital, Singapore

OTHER

Sponsor Role lead

Principal Investigators

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Ross Andrew Soo, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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MC01/03/07

Identifier Type: -

Identifier Source: org_study_id

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