Evaluation of Diagnostic Value of Molecular Markers in Re... | NCT00491621

Studies
Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

NCT00491621

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Terminated

Last Update Posted

Jun 4, 2015Estimated

Enrollment

74Actual

Phase

Not Applicable

Conditions

Kidney Neoplasms

Interventions

surgery or biopsy of the kidney tumor

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

No enough inclusion. The aim is no longer relevant. The sponsor decided to stop this study.

Expanded Access Info

Start Date

Apr 2007

Primary Completion Date

Sep 2014Actual

Completion Date

Sep 2014Actual

First Submitted Date

Jun 25, 2007

First Submission Date that Met QC Criteria

Jun 25, 2007

First Posted Date

Jun 26, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 3, 2015

Last Update Posted Date

Jun 4, 2015Estimated

Name	Class
Ministry of Health, France	OTHER_GOV

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

74Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Other	surgery or biopsy of the kidney tumor	Procedure: surgery or biopsy of the kidney tumor

Interventions

Name	Type	Description	Arm Group Labels	Other Names
surgery or biopsy of the kidney tumor	Procedure	surgery or biopsy of the kidney tumor	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Histologic diagnostic (tumor)		after surgery or biopsy

Secondary Outcomes

Measure	Description	Time 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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jacques TOSTAIN, PhD-MD	CHU de Saint-Etienne	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
CHU de Grenoble		Grenoble		38043	France
Hospices Civils de Lyon - Edouard Herriot

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16387417	Background	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.
14695146	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.

ID	Term
D014571	Urologic Neoplasms
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D052776	Female Urogenital Diseases

ID	Term
D007680	Kidney Neoplasms
D009369	Neoplasms