- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01173445
Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma
A Pilot Study on the Assessment of Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma
Study Overview
Status
Conditions
Detailed Description
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
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kansas
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Kansas City, Kansas, United States, 66160
- University of Kansas Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any patient with radiographic or histologic evidence of renal cell carcinoma who is scheduled to begin treatment with one of the following antiangiogenic agents: sunitinib, sorafenib, temsirolimus or bevacizumab.
- Patients must be candidates to be treated with one of the above agents but there is no limit on the number of prior therapies (i.e. first line or subsequent treatment setting).
- Patients scheduled to undergo debulking nephrectomy prior to beginning systemic therapy do not require histologic diagnosis prior to baseline testing.
- Must be able and willing to sign informed consent.
- Patients must be 18 years or older.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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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.
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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.
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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.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Peter J VanVeldhuizen, MD, University of Kansas Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Neoplasms by Histologic Type
- Neoplasms
- Urologic Neoplasms
- Urogenital Neoplasms
- Neoplasms by Site
- Kidney Diseases
- Urologic Diseases
- Adenocarcinoma
- Neoplasms, Glandular and Epithelial
- Kidney Neoplasms
- Neoplastic Processes
- Neoplasm Metastasis
- Carcinoma, Renal Cell
- Carcinoma
- Neoplastic Cells, Circulating
Other Study ID Numbers
- 12203
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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National Cancer Institute (NCI)Canadian Cancer Trials GroupActive, not recruitingUnresectable Renal Cell Carcinoma | Stage III Renal Cell Cancer AJCC v7 | Stage IV Renal Cell Cancer AJCC v7 | Type 1 Papillary Renal Cell Carcinoma | Type 2 Papillary Renal Cell Carcinoma | Metastatic Papillary Renal Cell Carcinoma | Locally Advanced Papillary Renal Cell CarcinomaUnited States, Canada
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