Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma
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|ClinicalTrials.gov Identifier: NCT01173445|
Recruitment Status : Completed
First Posted : August 2, 2010
Last Update Posted : October 20, 2011
|Condition or disease|
|Renal Cell Carcinoma|
Circulating tumors cells (CTCs) and circulating endothelial cells (CECs) are found in the peripheral blood of most common malignancies and are promising surrogate biomarkers. The CellSearchTM CTC assay is currently approved by the Food and Drug Administration as an adjunct for monitoring disease status in breast, prostate and colon carcinomas; and evidence in breast cancer suggests that CTCs are an independent predictor of overall survival and progression-free survival. Evolving data demonstrates a potential role of CTCs as a surrogate assessment for treatment response. The benefit of this approach in renal cell cancer(RCC) is unknown and further investigation is needed to determine the feasibility of using the CellSearchTM CTC Assay in this malignancy.
Circulating endothelial cells (CECs) are increased in the peripheral blood of cancer patients and appear to be a marker of tumor related angiogenesis. Studies suggest that CECs increase in the setting of progressive disease and decrease in response to treatment with an antiangiogenic agent. Although current data evaluating CECs in RCC is limited, there is significant interest in CEC evaluation as a marker of treatment response given the majority of current FDA approved RCC therapies target tumor angiogenesis.
The overall objective of this protocol is to obtain preliminary data and experience using our Cell Search Assay system which can be used for future grant applications. Our hypothesis is that CTCs and/or CECs will be valuable and versatile biomarkers for therapeutic response, determination of relapse and survival in patients with renal cell cancer.
|Study Type :||Observational|
|Actual Enrollment :||19 participants|
|Official Title:||A Pilot Study on the Assessment of Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||May 2011|
|Actual Study Completion Date :||May 2011|
- Determine if the number of CTCs and CECs in subject's blood changes with treatment. [ Time Frame: Pre-nephrectomy subjects - one week prior to beginning treatment and at first planned radiologic assessment. Other subjects will be collected at baseline and at time of first radiograph assessment of response. ]Subject samples will be used to see if CTCs and/or CECs will be valuable and versatile biomarkers for therapeutic response, determination of relapse and survival in patients with renal cell cancer.
Biospecimen Retention: None Retained
Blood samples will be collected at the following times:
- one draw prior to treatment initiation
- one draw after completion of two treatment cycles
- one draw at the time of disease progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173445
|United States, Kansas|
|University of Kansas Medical Center|
|Kansas City, Kansas, United States, 66160|
|Principal Investigator:||Peter J VanVeldhuizen, MD||University of Kansas Medical Center|