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Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

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

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00491621
Acronym
CMM
Enrollment
74
Registered
2007-06-26
Start date
2007-04-30
Completion date
2014-09-30
Last updated
2015-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Kidney Neoplasms

Keywords

kidney, tumor, Molecular Markers, Cytology, Histology, Cystic kidney tumor

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.

Interventions

PROCEDUREsurgery or biopsy of the kidney tumor

surgery or biopsy of the kidney tumor

Sponsors

Ministry of Health, France
CollaboratorOTHER_GOV
Centre Hospitalier Universitaire de Saint Etienne
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

Design outcomes

Primary

MeasureTime frame
Histologic diagnostic (tumor)after surgery or biopsy

Secondary

MeasureTime frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026