Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

Kidney Neoplasms Clinical Trial

— CMM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00491621
• Other study ID #: 0501106
• Status: Terminated
• Phase: N/A
• First received: June 25, 2007
• Last updated: June 3, 2015
• Start date: April 2007
• Est. completion date: September 2014

Study information

• Verified date: June 2015
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: French Data Protection AuthorityFrance: Institutional Ethical CommitteeFrance: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Kidney Neoplasms

Intervention

Procedure:
• surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor

Locations

Country	Name	City	State
France	CHU de Grenoble	Grenoble
France	Hospices Civils de Lyon - Edouard Herriot	LYON cedex 03
France	AP-HM Hôpital Nord	Marseille
France	AP-HM Hôpital Salvator	Marseille
France	CHU de Nancy	Nancy
France	CHU de Saint-Etienne	Saint-etienne
France	CHU de Toulouse	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (5)

Li G, Barthelemy A, Feng G, Gentil-Perret A, Peoc'h M, Genin C, Tostain J. S100A1: a powerful marker to differentiate chromophobe renal cell carcinoma from renal oncocytoma. Histopathology. 2007 Apr;50(5):642-7. — View Citation

Li G, Cuilleron M, Cottier M, Gentil-Perret A, Lambert C, Genin C, Tostain J. The use of MN/CA9 gene expression in identifying malignant solid renal tumors. Eur Urol. 2006 Feb;49(2):401-5. Epub 2005 Dec 19. — View Citation

Li G, Cuilleron M, Gentil-Perret A, Cottier M, Passebosc-Faure K, Lambert C, Genin C, Tostain J. Rapid and sensitive detection of messenger RNA expression for molecular differential diagnosis of renal cell carcinoma. Clin Cancer Res. 2003 Dec 15;9(17):6441-6. — View Citation

Li G, Feng G, Gentil-Perret A, Genin C, Tostain J. CA9 gene expression in conventional renal cell carcinoma: a potential marker for prediction of early metastasis after nephrectomy. Clin Exp Metastasis. 2007;24(3):149-55. Epub 2007 Mar 28. — View Citation

Li G, Gentil-Perret A, Lambert C, Genin C, Tostain J. S100A1 and KIT gene expressions in common subtypes of renal tumours. Eur J Surg Oncol. 2005 Apr;31(3):299-303. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Histologic diagnostic (tumor)		after surgery or biopsy	No
Secondary	Cytology-molecular tumor markers association diagnostic (tumor)		after surgery or biopsy	No
Secondary	Molecular tumor markers association diagnostic (blood + urine)		3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy	No