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T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00717743
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : April 9, 2010
Information provided by:
National University Hospital, Singapore

Brief Summary:

To define the frequency of T regulatory cells in peripheral blood of RCC patients before and after nephrectomy.

Study hypothesis: That nephrectomy results in a normalisation of peripheral blood T regs in early stage RCC, and a lowering of T regs in advanced RCC.

Condition or disease
Renal Cell Carcinoma

Detailed Description:

T regulatory cells (T regs) are a recently identified subset of T cells with inhibitory functions on the immune system. In cancer, it has been shown that there is an increased proportion of T regs in several different human malignancy states. T regs are found to be elevated in peripheral blood mononuclear cells, draining lymph nodes and in the primary tumor itself. There has also been correlation between peripheral blood T regs and tumor stage, tumor relapse and survival. It has been proposed that the T regs are activated and expanded by factors produced by the tumor microenvironment. They are thought to play a role in preventing or demising host T-cell responses against cancer, including a suboptimal host responses to vaccine strategies. Strategies to reduce T regs in cancer patients are being explored as a novel immunologic anti-cancer approach.

Renal cell cancer (RCC) is a tumor with well-known immune-mediated phenomena such as spontaneous regression. There is paucity of data on T regs in RCC. We propose to study the frequency of peripheral blood T regs before and after nephrectomy for RCC. We will document the baseline frequency of T regs in RCC and if nephrectomy results in a change in levels. We hypothesize that nephrectomy will lower peripheral T regs to normal levels in early stage RCC, and will reduce peripheral T reg levels in advanced RCC patients. If found to be so, T regs could in future be used as an indicator of disease recurrence in early stage RCC. In advanced RCC, lowering of T reg levels may help explain the previous hypothesis that debulking nephrectomy results in improved anti-tumor immunity, provide rationale for second debulking procedures, and be correlated with subsequent clinical course.

The main laboratory technique is flow cytometry. This will be a pilot study with small patient numbers. Only blood samples are required.

Study Type : Observational
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)
Study Start Date : March 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Patients diagnosed with RCC.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
RCC patients scheduled for nephrectomy

Inclusion Criteria:

Subjects must meet all of the inclusion criteria to participate in this study:

  • Diagnosed Renal Cell Carcinoma patients for whom nephrectomy is planned or scheduled as treatment. (Preoperative histologic diagnosis is not required.)
  • All stages of disease are eligible.
  • Adult patients above 21.
  • Ability to provide informed consent

Exclusion Criteria:

Subjects meeting any of the exclusion criteria at baseline will be excluded:

  • Active infection.
  • Immunocompromised or other active immune disorders.
  • Not on any immunomodulating therapy.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00717743

National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Principal Investigator: Alvin Seng Cheong Wong, MBBS, MRCP National University Hospital, Singapore
Principal Investigator: Chin Tiong Heng Tan Tock Seng Hospital Identifier: NCT00717743     History of Changes
Other Study ID Numbers: RC02/31/06
First Posted: July 17, 2008    Key Record Dates
Last Update Posted: April 9, 2010
Last Verified: April 2010

Keywords provided by National University Hospital, Singapore:

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases