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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:
NCT00491621
First received: June 25, 2007
Last updated: August 8, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention
Kidney Neoplasms
Procedure: surgery or biopsy of the kidney tumor

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Study Evaluating the Interest of Cytology-molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • Histologic diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cytology-molecular tumor markers association diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ]
  • Molecular tumor markers association diagnostic (blood + urine) [ Time Frame: 3, 6, 9, 12, 15, 18, 21 and 24 months after biopsy ] [ Designated as safety issue: No ]

Enrollment: 74
Study Start Date: April 2007
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
surgery or biopsy of the kidney tumor
Procedure: surgery or biopsy of the kidney tumor
surgery or biopsy of the kidney tumor

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00491621

Locations
France
CHU de Grenoble
Grenoble, France, 38043
Hospices Civils de Lyon - Edouard Herriot
LYON cedex 03, France, 69437
AP-HM Hôpital Nord
Marseille, France, 13015
AP-HM Hôpital Salvator
Marseille, France, 13274
CHU de Nancy
Nancy, France, 54511
CHU de Saint-Etienne
Saint-etienne, France, 42055
CHU de Toulouse
Toulouse, France, 31403
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Ministry of Health, France
Investigators
Study Chair: Jacques TOSTAIN, PhD-MD CHU de Saint-Etienne
  More Information

Publications:
Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT00491621     History of Changes
Other Study ID Numbers: 0501106
Study First Received: June 25, 2007
Last Updated: August 8, 2014
Health Authority: France: French Data Protection Authority
France: Institutional Ethical Committee
France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
kidney
tumor
Molecular Markers
Cytology
Histology
Cystic kidney tumor

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 18, 2014