An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy
|ClinicalTrials.gov Identifier: NCT00538772|
Recruitment Status : Withdrawn
First Posted : October 3, 2007
Last Update Posted : November 5, 2010
The purpose of the correlative studies is to evaluate levels of serum factors of circulating VEGF and soluble VEGFR, circulating tumor cells and circulating endothelial cells assayed at baseline and over the course of initial treatment in order to explore relationships with baseline patient factors, measurable disease response and clinical progression.
Hypothesis soluble markers of angiogenic growth factors and receptors, and circulating endothelial and tumor cells can serve as markers for biologic activity of temsirolimus and/or sorafenib.
|Condition or disease||Intervention/treatment|
|Carcinoma, Renal Cell||Other: Not applicable - blood tests/tissue specimen tests will be undertaken|
|Study Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||An Exploratory Correlative Study of Biomarkers in Patients With Metastatic Renal Cell Carcinoma Who Have Progressed After Sunitinib Therapy|
|Study Start Date :||July 2008|
Other: Not applicable - blood tests/tissue specimen tests will be undertaken
Not applicable - blood tests/tissue specimen tests will be undertaken
- This is an exploratory study. Correlations between biomarkers and baseline factors and treatment outcomes will be made
Biospecimen Retention: Samples With DNA
Approx. 40ml of blood for correlative studies will be drawn at predetermined time points: baseline, after cycle 1, at time of treatment failure/discontinuation of protocol therapy.
10 unstained slides from original patient specimen (nephrectomy specimens only) will be collected within 6 months after enrollment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00538772
|Canada, British Columbia|
|BC Cancer Agency - Centre for Southern Interior|
|Kelowna, British Columbia, Canada, V1Y 5L3|
|BC Cancer Agency - Vancouver|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|BC Cancer Agency - Vancouver Island|
|Victoria, British Columbia, Canada, V8R 6V5|
|Principal Investigator:||Christian Kollmannsberger, MD||BC Cancer Agency- Vancouver|