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Sponsors and Collaborators: |
Centre Hospitalier Universitaire de Saint Etienne Ministry of Health, France |
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Information provided by: | Centre Hospitalier Universitaire de Saint Etienne |
ClinicalTrials.gov Identifier: | NCT00491621 |
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 |
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Kidney Neoplasms |
Procedure: surgery or biopsy of the kidney tumor |
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 |
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 |
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1
surgery or biopsy of the kidney tumor
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Procedure: surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
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 |
Principal Investigator: | Jacques TOSTAIN, PhD-MD | CHU de Saint-Etienne |
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 |
kidney tumor Molecular Markers |
Cytology Histology Cystic kidney tumor |
Urologic Diseases Kidney Neoplasms Carcinoma, Renal Cell Urogenital Neoplasms Renal cancer |
Kidney Diseases Kidney cancer Urologic Neoplasms Urinary tract neoplasm |
Neoplasms Neoplasms by Site |