T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

April 7, 2010 updated by: National University Hospital, Singapore

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

RCC patients scheduled for nephrectomy

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Patients diagnosed with RCC.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Investigators

  • Principal Investigator: Alvin Seng Cheong Wong, MBBS, MRCP, National University Hospital, Singapore
  • Principal Investigator: Chin Tiong Heng, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

July 16, 2008

First Posted (Estimate)

July 17, 2008

Study Record Updates

Last Update Posted (Estimate)

April 9, 2010

Last Update Submitted That Met QC Criteria

April 7, 2010

Last Verified

April 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC02/31/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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