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Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)
This study is currently recruiting participants.
Study NCT00491621   Information provided by Centre Hospitalier Universitaire de Saint Etienne
First Received: June 25, 2007   Last Updated: June 8, 2009   History of Changes

June 25, 2007
June 8, 2009
April 2007
January 2012   (final data collection date for primary outcome measure)
Histologic diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]
histologic diagnostic [ Time Frame: after surgery or biopsy ]
Complete list of historical versions of study NCT00491621 on ClinicalTrials.gov Archive Site
  • Cytology-molecular tumor markers association diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]
  • Molecular tumor markers association diagnostic (blood + urine) [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy ] [ Designated as safety issue: No ]
Cytology-molecular tumor markers association diagnostic [ Time Frame: after surgery or biopsy ]
 
Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer
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.

 
 
Interventional
Diagnostic, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Kidney Neoplasms
Procedure: surgery or biopsy of the kidney tumor
Other: surgery or biopsy of the kidney tumor

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
156
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Jacques TOSTAIN, PhD-MD +33 477828331 jacques.tostain@chu-st-etienne.fr
Contact: Guorong LI, PhD-MD +33 477828379 guorong.li@univ-st-etienne.fr
France
 
NCT00491621
Clément CAILLAUX, Centre Hospitalier Universitaire de Saint Etienne
0501106
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Principal Investigator: Jacques TOSTAIN, PhD-MD CHU de Saint-Etienne
Centre Hospitalier Universitaire de Saint Etienne
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP