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Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)
This study is currently recruiting participants.
Verified by Centre Hospitalier Universitaire de Saint Etienne, October 2008
Sponsors and Collaborators: Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Information provided by: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00491621
  Purpose

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.


Condition Intervention
Kidney Neoplasms
Procedure: surgery or biopsy of the kidney tumor

MedlinePlus related topics: Cancer Kidney Cancer
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title: Study Evaluating the Interest of Cytology-Molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Histologic diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 156
Study Start Date: April 2007
Estimated Study Completion Date: January 2012
Estimated Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
surgery or biopsy of the kidney tumor
Procedure: surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00491621

Contacts
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

Locations
France
CHU de Saint-Etienne Recruiting
SAINT-ETIENNE, France, 42055
Principal Investigator: Jacques TOSTAIN, MD, PhD            
Sub-Investigator: Jean-Michel MOREAU, MD            
Sub-Investigator: Bastien RAMBAUD, MD            
Sub-Investigator: Mathias CORNELOUP, MD            
AP-HM Hôpital Salvator Not yet recruiting
MARSEILLE, France, 13274
Principal Investigator: Christian COULLANGE, MD, PhD            
Sub-Investigator: Eric LECHEVALLIER, MD, PhD            
AP-HM Hôpital Nord Not yet recruiting
MARSEILLE, France, 13015
Principal Investigator: Dominique ROSSI, MD, PhD            
Hospices Civils de Lyon - Edouard Herriot Not yet recruiting
LYON cedex 03, France, 69437
Principal Investigator: Marc COLOMBEL, MD, PhD            
CHU de Nancy Not yet recruiting
NANCY, France, 54511
Principal Investigator: Phillipe MANGIN, MD, PhD            
Sub-Investigator: Jacques HUBERT, MD, PhD            
CHU de Grenoble Recruiting
GRENOBLE, France, 38043
Sub-Investigator: Jean-Luc DESCOTES, MD, PhD            
Principal Investigator: Jean-Jacques RAMBEAUD, MD, PhD            
Sub-Investigator: Nicolas TERRIER, MD            
Sub-Investigator: Pierre CADI, MD            
Sub-Investigator: Jean-Alexandre LONG, MD            
CHU de Toulouse Not yet recruiting
TOULOUSE, France, 31403
Principal Investigator: Pierre PLANTE, MD, PhD            
Sub-Investigator: Pascal RICHMANN, MD, PhD            
Sub-Investigator: Michel SOULIE, MD, PhD            
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Principal Investigator: Jacques TOSTAIN, PhD-MD CHU de Saint-Etienne
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne ( Françoise LORCA )
Study ID Numbers: 0501106
Study First Received: June 25, 2007
Last Updated: October 14, 2008
ClinicalTrials.gov Identifier: NCT00491621  
Health Authority: France: French Data Protection Authority;   France: Institutional Ethical Committee;   France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
kidney
tumor
Molecular Markers
Cytology
Histology
Cystic kidney tumor

Study placed in the following topic categories:
Urologic Diseases
Kidney Neoplasms
Carcinoma, Renal Cell
Urogenital Neoplasms
Renal cancer
Kidney Diseases
Kidney cancer
Urologic Neoplasms
Urinary tract neoplasm

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009