T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)
|ClinicalTrials.gov Identifier: NCT00717743|
Recruitment Status : Completed
First Posted : July 17, 2008
Last Update Posted : April 9, 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.
|Condition or disease|
|Renal Cell Carcinoma|
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|
|Official Title:||T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)|
|Study Start Date :||March 2007|
Patients diagnosed with RCC.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00717743
|National University Hospital|
|Principal Investigator:||Alvin Seng Cheong Wong, MBBS, MRCP||National University Hospital, Singapore|
|Principal Investigator:||Chin Tiong Heng||Tan Tock Seng Hospital|