|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | June 25, 2007 | ||||||||
| Last Updated Date | June 8, 2009 | ||||||||
| Start Date ICMJE | April 2007 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Histologic diagnostic (tumor) [ Time Frame: after surgery or biopsy ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE |
histologic diagnostic [ Time Frame: after surgery or biopsy ] | ||||||||
| Change History | Complete list of historical versions of study NCT00491621 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
|
||||||||
| Original Secondary Outcome Measures ICMJE |
Cytology-molecular tumor markers association diagnostic [ Time Frame: after surgery or biopsy ] | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation of Diagnostic Value of Molecular Markers in Renal Cancer | ||||||||
| Official Title ICMJE | Study Evaluating the Interest of Cytology-Molecular Tumor Markers Association for the Diagnostic Strategy in Adult Kidney Tumors | ||||||||
| 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 | |||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Diagnostic, Open Label, Historical Control, Single Group Assignment, Efficacy Study | ||||||||
| Condition ICMJE | Kidney Neoplasms | ||||||||
| Intervention ICMJE | Procedure: surgery or biopsy of the kidney tumor | ||||||||
| Study Arms / Comparison Groups | Other: surgery or biopsy of the kidney tumor | ||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 156 | ||||||||
| Estimated Completion Date | January 2012 | ||||||||
| Estimated Primary Completion Date | January 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | France | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00491621 | ||||||||
| Responsible Party | Clément CAILLAUX, Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Study ID Numbers ICMJE | 0501106 | ||||||||
| Study Sponsor ICMJE | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Collaborators ICMJE | Ministry of Health, France | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Centre Hospitalier Universitaire de Saint Etienne | ||||||||
| Verification Date | June 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||