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T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)
This study is currently recruiting participants.
Verified by National University Hospital, Singapore, July 2008
Sponsored by: National University Hospital, Singapore
Information provided by: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00717743
  Purpose

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
Renal Cell Carcinoma

U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: T Regulatory Cells in Renal Cell Carcinoma (PILOT STUDY)

Further study details as provided by National University Hospital, Singapore:

Study Start Date: March 2007
Groups/Cohorts
1
Patients diagnosed with 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

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

RCC patients scheduled for nephrectomy

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717743

Contacts
Contact: Alvin Seng Cheong Wong, MBBS, MRCP 65-6772-2527 Alvin_SC_Wong@nuh.com.sg

Locations
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    
Sponsors and Collaborators
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
  More Information

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

Keywords provided by National University Hospital, Singapore:
RCC
patients
scheduled
nephrectomy

Study placed in the following topic categories:
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

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on January 16, 2009