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Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00491621
Recruitment Status : Terminated (No enough inclusion. The aim is no longer relevant. The sponsor decided to stop this study.)
First Posted : June 26, 2007
Last Update Posted : June 4, 2015
Ministry of Health, France
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Kidney Neoplasms Procedure: surgery or biopsy of the kidney tumor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 74 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Study Evaluating the Interest of Cytology-molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors
Study Start Date : April 2007
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
surgery or biopsy of the kidney tumor
Procedure: surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor

Primary Outcome Measures :
  1. Histologic diagnostic (tumor) [ Time Frame: after surgery or biopsy ]

Secondary Outcome Measures :
  1. Cytology-molecular tumor markers association diagnostic (tumor) [ Time Frame: after surgery or biopsy ]
  2. Molecular tumor markers association diagnostic (blood + urine) [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00491621

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CHU de Grenoble
Grenoble, France, 38043
Hospices Civils de Lyon - Edouard Herriot
LYON cedex 03, France, 69437
AP-HM Hôpital Nord
Marseille, France, 13015
AP-HM Hôpital Salvator
Marseille, France, 13274
CHU de Nancy
Nancy, France, 54511
CHU de Saint-Etienne
Saint-etienne, France, 42055
CHU de Toulouse
Toulouse, France, 31403
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
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Study Chair: Jacques TOSTAIN, PhD-MD CHU de Saint-Etienne

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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne Identifier: NCT00491621    
Other Study ID Numbers: 0501106
First Posted: June 26, 2007    Key Record Dates
Last Update Posted: June 4, 2015
Last Verified: June 2015
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Molecular Markers
Cystic kidney tumor
Additional relevant MeSH terms:
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Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases