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Spots Global Cancer Trial Database for T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

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Trial Identification

Brief Title: T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

Official Title: T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

Study ID: NCT00717743

Interventions

Study Description

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.

Eligibility

Minimum Age: 21 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

National University Hospital, Singapore, , Singapore

Contact Details

Name: Alvin Seng Cheong Wong, MBBS, MRCP

Affiliation: National University Hospital, Singapore

Role: PRINCIPAL_INVESTIGATOR

Name: Chin Tiong Heng

Affiliation: Tan Tock Seng Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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