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Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer (CMM)

Primary Purpose

Kidney Neoplasms

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
surgery or biopsy of the kidney tumor
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Kidney Neoplasms focused on measuring kidney, tumor, Molecular Markers, Cytology, Histology, Cystic kidney tumor

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Grenoble
  • Hospices Civils de Lyon - Edouard Herriot
  • AP-HM Hôpital Nord
  • AP-HM Hôpital Salvator
  • CHU de Nancy
  • CHU de Saint-Etienne
  • CHU de Toulouse

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

surgery or biopsy of the kidney tumor

Outcomes

Primary Outcome Measures

Histologic diagnostic (tumor)

Secondary Outcome Measures

Cytology-molecular tumor markers association diagnostic (tumor)
Molecular tumor markers association diagnostic (blood + urine)

Full Information

First Posted
June 25, 2007
Last Updated
June 3, 2015
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT00491621
Brief Title
Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer
Acronym
CMM
Official Title
Study Evaluating the Interest of Cytology-molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
No enough inclusion. The aim is no longer relevant. The sponsor decided to stop this study.
Study Start Date
April 2007 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Kidney Neoplasms
Keywords
kidney, tumor, Molecular Markers, Cytology, Histology, Cystic kidney tumor

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
74 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
surgery or biopsy of the kidney tumor
Intervention Type
Procedure
Intervention Name(s)
surgery or biopsy of the kidney tumor
Intervention Description
surgery or biopsy of the kidney tumor
Primary Outcome Measure Information:
Title
Histologic diagnostic (tumor)
Time Frame
after surgery or biopsy
Secondary Outcome Measure Information:
Title
Cytology-molecular tumor markers association diagnostic (tumor)
Time Frame
after surgery or biopsy
Title
Molecular tumor markers association diagnostic (blood + urine)
Time Frame
3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques TOSTAIN, PhD-MD
Organizational Affiliation
CHU de Saint-Etienne
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Grenoble
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hospices Civils de Lyon - Edouard Herriot
City
LYON cedex 03
ZIP/Postal Code
69437
Country
France
Facility Name
AP-HM Hôpital Nord
City
Marseille
ZIP/Postal Code
13015
Country
France
Facility Name
AP-HM Hôpital Salvator
City
Marseille
ZIP/Postal Code
13274
Country
France
Facility Name
CHU de Nancy
City
Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
CHU de Saint-Etienne
City
Saint-etienne
ZIP/Postal Code
42055
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
ZIP/Postal Code
31403
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
16387417
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. doi: 10.1016/j.eururo.2005.10.025. Epub 2005 Dec 19.
Results Reference
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PubMed Identifier
14695146
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.
Results Reference
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PubMed Identifier
17394501
Citation
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.
Results Reference
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PubMed Identifier
17390110
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. doi: 10.1007/s10585-007-9064-z. Epub 2007 Mar 28.
Results Reference
background
PubMed Identifier
15780567
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. doi: 10.1016/j.ejso.2004.11.009.
Results Reference
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Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer

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