Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Kidney Neoplasms

Intervention / Treatment
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* Procedure: surgery or biopsy of the kidney tumor


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>surgery or biopsy of the kidney tumor | Procedure: surgery or biopsy of the kidney tumor<br>* surgery or biopsy of the kidney tumor<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histologic diagnostic (tumor) |  | after surgery or biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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kidney, tumor, Molecular Markers, Cytology, Histology, Cystic kidney tumor