Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)

June 3, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Study Evaluating the Interest of Cytology-molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors

Renal cancer is frequent and its diagnosis mainly dependant on imaging. More than 50% of renal tumors are currently diagnosed without symptoms. However, 20% of small solid tumors are benign and this percentage is much higher in atypical cystic tumors Bosniak II and III, where 76% and 59% are benign respectively. Determining the malignancy by imaging in these cases is difficult and sometimes impossible. The fine needle aspiration (FNA) cytology or biopsy is necessary. The diagnostic sensitivity and specificity with biopsy are high, but the potential tumor contamination is a major risk. The FNA cytology is simple and safe, but its sensitivity is about 50%. We are conducting a multicentric prospective study to add the molecular markers in FNA cytology as a new diagnostic method in imaging-indeterminate renal tumors.

Four molecular markers including MN/CA9, vimentin, KIT, and S100A1 will be studied. These four markers have been reported to have a differential diagnostic value in renal tumors. MN/CA9 and vimentin are often found in conventional renal cancers. KIT is frequently expressed in renal oncocytomas and chromophobe renal cancers. S100A1 may further distinguish renal oncocytoma from chromophobe renal cancer. These markers will be analyzed by real time polymerase chain reaction (RT-PCR).

The aim of this study is to evaluate the diagnostic performance of the association cytology-molecular markers in imaging-indeterminate renal tumors (small solid tumors and cystic tumors ≥ Bosniak III). About 156 patients will be included in five French clinical centers including Saint-Etienne, Marseille, Grenoble, Toulouse, and Nancy.

The expected results will improve the preoperative diagnostic accuracy in renal tumors.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

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

  • France
      • Grenoble, France, 38043
        • Chu de Grenoble
      • LYON cedex 03, France, 69437
        • Hospices Civils de Lyon - Edouard Herriot
      • Marseille, France, 13015
        • AP-HM Hôpital Nord
      • Marseille, France, 13274
        • AP-HM Hôpital Salvator
      • Nancy, France, 54511
        • Chu de Nancy
      • Saint-etienne, France, 42055
        • CHU de Saint-Etienne
      • Toulouse, France, 31403
        • CHU de Toulouse

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinical diagnosis of kidney tumor < 4 cm
  • Cystic kidney tumor (Bosniak > IIF)
  • Consent signed

Exclusion Criteria:

  • Benign tumor confirmed
  • Impossibility to do abdominal pelvic ultra-sound or abdominal thoracic scanner
  • Contraindication for renal puncture

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: 1
surgery or biopsy of the kidney tumor
Procedure: surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Histologic diagnostic (tumor)
Time Frame: after surgery or biopsy
after surgery or biopsy

Secondary Outcome Measures

Outcome Measure
Time Frame
Cytology-molecular tumor markers association diagnostic (tumor)
Time Frame: after surgery or biopsy
after surgery or biopsy
Molecular tumor markers association diagnostic (blood + urine)
Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy
3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Collaborators

Ministry of Health, France

Investigators

  • Study Chair: Jacques TOSTAIN, PhD-MD, CHU de Saint-Etienne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

April 1, 2007

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

June 25, 2007

First Submitted That Met QC Criteria

June 25, 2007

First Posted (ESTIMATE)

June 26, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 4, 2015

Last Update Submitted That Met QC Criteria

June 3, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0501106

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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