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T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00717743
Enrollment
Unknown
Registered
2008-07-17
Start date
2007-03-31
Completion date
Unknown
Last updated
2010-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Cell Carcinoma

Keywords

RCC, patients, scheduled, nephrectomy

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.

Interventions

None listed

Sponsors

National University Hospital, Singapore
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026