Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

NCT00491621 | Terminated

• 1 other identifier: 0501106
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 7

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.

Conditions

Kidney Neoplasms

Keywords

kidney; tumor; Molecular Markers; Cytology; Histology; Cystic kidney tumor

Outcome Measures

Primary Outcomes (1)

• Histologic diagnostic (tumor)

  after surgery or biopsy

Secondary Outcomes (2)

• 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

Study Arms (1)

1

OTHER

surgery or biopsy of the kidney tumor

Procedure: surgery or biopsy of the kidney tumor

Interventions

surgery or biopsy of the kidney tumor PROCEDURE

surgery or biopsy of the kidney tumor

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of kidney tumor \< 4 cm
• Cystic kidney tumor (Bosniak \> IIF)
• Consent signed

You may not qualify if:

• Benign tumor confirmed
• Impossibility to do abdominal pelvic ultra-sound or abdominal thoracic scanner
• Contraindication for renal puncture

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Saint Etienne: lead
• Ministry of Health, France: collaborator

Study Sites (7)

CHU de Grenoble

Grenoble, 38043, France

Location

Hospices Civils de Lyon - Edouard Herriot

Lyon, 69437, France

Location

AP-HM Hôpital Nord

Marseille, 13015, France

Location

AP-HM Hôpital Salvator

Marseille, 13274, France

Location

CHU de Nancy

Nancy, 54511, France

Location

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

CHU de Toulouse

Toulouse, 31403, France

Location

Related Publications (5)

• 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. doi: 10.1016/j.eururo.2005.10.025. Epub 2005 Dec 19.

  PMID: 16387417 BACKGROUND

• 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.

  PMID: 14695146 BACKGROUND

• 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. doi: 10.1111/j.1365-2559.2007.02655.x.

  PMID: 17394501 BACKGROUND

• 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. doi: 10.1007/s10585-007-9064-z. Epub 2007 Mar 28.

  PMID: 17390110 BACKGROUND

• 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. doi: 10.1016/j.ejso.2004.11.009.

  PMID: 15780567 BACKGROUND

MeSH Terms

Conditions

Kidney Neoplasms; Neoplasms

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jacques TOSTAIN, PhD-MD

  CHU de Saint-Etienne

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2007
• First Posted: June 26, 2007
• Study Start: April 1, 2007
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 4, 2015

Record last verified: 2015-06

Locations

FR (7)