An observational study in Renal Cell Carcinoma, sponsored by University of Kansas. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-10-20.
Sponsored by University of Kansas · Observational
The purpose of this study is to see if researchers can detect circulating tumor cells (CTC) and circulating endothelial cells (CEC) in the blood.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 19 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →University of Kansas is the lead sponsor of 81 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Eligible subjects will be approached for participation during regular Cancer Center clinic visits.
Inclusion Criteria:
Determine if the number of CTCs and CECs in subject's blood changes with treatment.
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.
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.
This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.
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University of Kansas