Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Kansas
ClinicalTrials.gov Identifier:
NCT01173445
First received: July 27, 2010
Last updated: October 19, 2011
Last verified: October 2011
  Purpose

The purpose of this study is to see if researchers can detect circulating tumor cells (CTC) and circulating endothelial cells (CEC) in the blood.


Condition
Renal Cell Carcinoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study on the Assessment of Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Kansas:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]
    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

Enrollment: 19
Study Start Date: July 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Eligible subjects will be approached for participation during regular Cancer Center clinic visits.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01173445

Locations
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
University of Kansas
Investigators
Principal Investigator: Peter J VanVeldhuizen, MD University of Kansas
  More Information

No publications provided

Responsible Party: University of Kansas
ClinicalTrials.gov Identifier: NCT01173445     History of Changes
Other Study ID Numbers: 12203
Study First Received: July 27, 2010
Last Updated: October 19, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Kansas:
cancer
kidney
renal cell
tumor cells
circulating tumor cells
circulating endothelial cells

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Neoplastic Cells, Circulating
Adenocarcinoma
Kidney Diseases
Kidney Neoplasms
Neoplasm Metastasis
Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Neoplastic Processes
Pathologic Processes
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014