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T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

21 Years
Not Enrolling
Renal Cell Carcinoma

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Trial Information

T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

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.

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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Principal Investigator

Alvin Seng Cheong Wong, MBBS, MRCP

Investigator Role:

Principal Investigator

Investigator Affiliation:

National University Hospital, Singapore


Singapore: Domain Specific Review Boards

Study ID:




Start Date:

March 2007

Completion Date:

Related Keywords:

  • Renal Cell Carcinoma
  • RCC
  • patients
  • scheduled
  • nephrectomy
  • Carcinoma
  • Carcinoma, Renal Cell