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Clinical Trials/NCT00491621
NCT00491621
Terminated
Not Applicable

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

Centre Hospitalier Universitaire de Saint Etienne7 sites in 1 country74 target enrollmentApril 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Kidney Neoplasms
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Enrollment
74
Locations
7
Primary Endpoint
Histologic diagnostic (tumor)
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2007
End Date
September 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Eligibility 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

Outcomes

Primary Outcomes

Histologic diagnostic (tumor)

Time Frame: after surgery or biopsy

Secondary Outcomes

  • 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)

Study Sites (7)

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