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Sponsored by: |
National University Hospital, Singapore |
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Information provided by: | National University Hospital, Singapore |
ClinicalTrials.gov Identifier: | NCT00717743 |
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 |
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Renal Cell Carcinoma |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY) |
Study Start Date: | March 2007 |
Groups/Cohorts |
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1
Patients diagnosed with RCC.
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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 |
RCC patients scheduled for nephrectomy
Inclusion Criteria:
Subjects must meet all of the inclusion criteria to participate in this study:
Exclusion Criteria:
Subjects meeting any of the exclusion criteria at baseline will be excluded:
Contact: Alvin Seng Cheong Wong, MBBS, MRCP | 65-6772-2527 | Alvin_SC_Wong@nuh.com.sg |
Singapore | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Alvin Seng Cheong Wong, MBBS, MRCP 65-6772-2527 Alvin_SC_Wong@nuh.com.sg | |
Principal Investigator: Alvin Seng Cheong Wong, MBBS, MRCP | |
Principal Investigator: Chin Tiong Heng | |
National University Hospital | Recruiting |
Singapore, Singapore | |
Contact: Alvin Seng Chong Wong, MBBS, MRCP 65-6772-2527 Alvin_SC_Wong@nuh.com.sg |
Principal Investigator: | Alvin Seng Cheong Wong, MBBS, MRCP | National University Hospital, Singapore |
Principal Investigator: | Chin Tiong Heng | Tan Tock Seng Hospital |
Study ID Numbers: | RC02/31/06 |
Study First Received: | July 16, 2008 |
Last Updated: | July 16, 2008 |
ClinicalTrials.gov Identifier: | NCT00717743 |
Health Authority: | Singapore: Domain Specific Review Boards |
RCC patients scheduled nephrectomy |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer Kidney Diseases |
Kidney cancer Urologic Neoplasms Adenocarcinoma Urinary tract neoplasm Neoplasms, Glandular and Epithelial Carcinoma |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type |