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A Pilot Study on the Assessment of Circulating Tumors Cells and Circulating Endothelial Cells in Renal Cell Carcinoma


N/A
18 Years
N/A
Not Enrolling
Both
Renal Cell Carcinoma

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Trial Information

A Pilot Study on the Assessment of Circulating Tumors Cells and Circulating Endothelial Cells in 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.


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.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Determine if the number of CTCs and CECs in subject's blood changes with treatment.

Outcome Description:

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.

Outcome 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.

Safety Issue:

No

Principal Investigator

Peter J VanVeldhuizen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Kansas

Authority:

United States: Institutional Review Board

Study ID:

12203

NCT ID:

NCT01173445

Start Date:

July 2010

Completion Date:

May 2011

Related Keywords:

  • Renal Cell Carcinoma
  • cancer
  • kidney
  • renal cell
  • tumor cells
  • circulating tumor cells
  • circulating endothelial cells
  • Carcinoma
  • Carcinoma, Renal Cell
  • Neoplastic Cells, Circulating

Name

Location

University of Kansas Medical CenterKansas City, Kansas  66160-7353