T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

Completed

• Conditions: Renal Cell Carcinoma

• Registration Number: NCT00717743
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2007-03
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-17
• Status Verified: 2010-04
• Last Update Submitted: 2010-04-07
• Last Update Posted: 2010-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

National University Hospital; 🇸🇬 Singapore, Singapore