Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)
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Purpose
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 |
|---|---|
|
Kidney Neoplasms |
Procedure: surgery or biopsy of the kidney tumor |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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 |
- Histologic diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]
- Cytology-molecular tumor markers association diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]
- Molecular tumor markers association diagnostic (blood + urine) [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy ] [ Designated as safety issue: No ]
| Enrollment: | 74 |
| Study Start Date: | April 2007 |
| Estimated Study Completion Date: | January 2015 |
| Estimated Primary Completion Date: | January 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1
surgery or biopsy of the kidney tumor
|
Procedure: surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations| France | |
| 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 | |
| Principal Investigator: | Jacques TOSTAIN, PhD-MD | CHU de Saint-Etienne |
More Information
Publications:
| Responsible Party: | Centre Hospitalier Universitaire de Saint Etienne |
| ClinicalTrials.gov Identifier: | NCT00491621 History of Changes |
| Other Study ID Numbers: | 0501106 |
| Study First Received: | June 25, 2007 |
| Last Updated: | July 23, 2012 |
| Health Authority: | France: French Data Protection Authority France: Institutional Ethical Committee France: Ministry of Health |
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
|
kidney tumor Molecular Markers |
Cytology Histology Cystic kidney tumor |
Additional relevant MeSH terms:
|
Neoplasms Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms |
Neoplasms by Site Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on May 19, 2013