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T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

This study has been completed.
Information provided by:
National University Hospital, Singapore Identifier:
First received: July 16, 2008
Last updated: April 7, 2010
Last verified: April 2010

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.

Renal Cell Carcinoma

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

Resource links provided by NLM:

Further study details as provided by National University Hospital, Singapore:

Study Start Date: March 2007
Patients diagnosed with RCC.

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.


Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

No publications provided Identifier: NCT00717743     History of Changes
Other Study ID Numbers: RC02/31/06
Study First Received: July 16, 2008
Last Updated: April 7, 2010
Health Authority: Singapore: Domain Specific Review Boards

Keywords provided by National University Hospital, Singapore:

Additional relevant MeSH terms:
Carcinoma, Renal Cell
Kidney Diseases
Kidney Neoplasms
Neoplasms by Histologic Type
Neoplasms by Site
Neoplasms, Glandular and Epithelial
Urogenital Neoplasms
Urologic Diseases
Urologic Neoplasms processed this record on November 20, 2014