Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

Not Applicable

Terminated

• Conditions: Kidney Neoplasms
• Interventions: Procedure: surgery or biopsy of the kidney tumor

• Registration Number: NCT00491621
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-06-25
• Study First Submitted QC: 2007-06-25
• Study First Posted: 2007-06-26
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-03
• Last Update Posted: 2015-06-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 74

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	surgery or biopsy of the kidney tumor	surgery or biopsy of the kidney tumor

Primary Outcome Measures

Name	Time	Method
Histologic diagnostic (tumor)	after surgery or biopsy

Secondary Outcome Measures

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

Trial Locations

Locations (7)

CHU de Nancy; 🇫🇷 Nancy, France

AP-HM Hôpital Salvator; 🇫🇷 Marseille, France

Hospices Civils de Lyon - Edouard Herriot; 🇫🇷 LYON cedex 03, France

CHU de Grenoble; 🇫🇷 Grenoble, France

AP-HM Hôpital Nord; 🇫🇷 Marseille, France

CHU de Saint-Etienne; 🇫🇷 Saint-etienne, France

CHU de Toulouse; 🇫🇷 Toulouse, France