Correlation of the Clinical Behaviour of Renal Cell Carcinoma (RCC) After Debulking Nephrectomy With Tumor Gene Expression in Nephrectomy Specimens

January 13, 2014 updated by: National University Hospital, Singapore
The objective of the study is to determine whether a specific immune microenvironment in the primary tumor is associated with a favorable clinical course after nephrectomy and in the absence of adjuvant treatment.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

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Detailed Description

Renal cell carcinoma (RCC) is a tumor with clinically apparent immunologic phenomena, such as response to immunotherapies (interferon, interleukin-2, immune cellular therapy etc), spontaneous regression, and sometimes indolent behaviour. Nephrectomy itself influences the prognosis of advanced RCC patients as shown in 2 randomised trials, and could have an immune basis. We previously reported on the variability of clinical behaviour in advanced RCC patients who had not received systemic treatment after debulking nephrectomy (Debulking Nephrectomy Followed By A "Watch And Wait" Approach In Metastatic Renal Cell Carcinoma .Wong A, et al. Urol Oncol, in press). The clinical significance of this includes the avoidance of toxic systemic therapies after nephrectomy, or the possibility of using non-toxic vaccine approaches in metastatic patients after cytoreductive nephrectomy. In this research proposal we would like to analyse the immune related gene expression profile on nephrectomy tumor samples and correlate them with the clinical course of the patient after the nephrectomy. This will be an exploratory and retrospective study of 15 patients in whom debulking nephrectomy for advanced RCC had been done, who did not receive any adjuvant treatment, and in whom the clinical course had been monitored after the nephrectomy.

We will first carry out a feasibility study during which we will isolate RNA from 3 FFPE (formalin-fixed,paraffin-embedded) samples using commercially available RNA isolation kit and we will determine if their quality is compatible with quantitative polymerase chain reaction (qPCR) or microarray studies. Upon successful feasibility study, the analysis will be extended to 15 patients. RNA will be isolated from FFPE samples and the gene expression profiles will be evaluated by qPCR and/or microarray. Emphasis will be placed on the expression profile of immune-related genes. Finally, transcriptome analysis results will be extended at the protein and cell level using immunohistochemistry assays.

Study Type

Study Type

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Observational

Contacts and Locations

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Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

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Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Advanced RCC who had a cytoreductive nephrectomy done. Patients did not receive specific anti-cancer systemic therapy after the nephrectomy, except after clinical disease progression. Tumor samples available.

Description

Inclusion Criteria:

  • Advanced RCC who had a cytoreductive nephrectomy done.
  • Patients did not receive specific anti-cancer systemic therapy after the nephrectomy, except after clinical disease progression.
  • Tumor samples available.

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

Collaborators and Investigators

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Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University Hospital, Singapore

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Alvin Seng Cheong Wong, MRCP, MB ChB, National University Hospital, Singapore
  • Principal Investigator: Sing Joo Chia, Tan Tock Seng Hospital

Publications and helpful links

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General Publications

Study record dates

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Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2008

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 16, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2008

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 18, 2008

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 14, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RC01/31/07

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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