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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00899613 |
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Date of registration:
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09/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia
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Scientific title:
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Study Aiming at Researching Diagnostic Markers for the Recognition of Precancerous States, Tracking, Follow-up, and the Identification of New Therapeutic Targets for Mesothelioma in Patients With Atypical Mesothelial Hyperplasia. |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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270 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT00899613 |
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Study type:
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Observational |
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Study design:
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N/A
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Francoise Galateau-Salle |
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Address:
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Telephone:
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Email:
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Affiliation:
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University Hospital, Caen |
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Name:
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Francoise Galateau-Salle |
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Address:
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Telephone:
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33-231-064-923 |
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Email:
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Affiliation:
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Key inclusion & exclusion criteria
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DISEASE CHARACTERISTICS:
Inclusion criteria:
- Diagnosis of mesothelial hyperplasia and meeting 1 of the following criteria:
- Confirmed prior exposure to asbestos and presence of pleural effusion and meets
1 of the following diagnostic criteria:
- Mesothelioma
- Mesothelial hyperplasia of unspecified malignancy
- Reactional inflammatory hyperplasia
- No asbestos exposure but pleural effusion with pleural malignant mesothelioma or
pulmonary metastasis
- Prior exposure to asbestos, no pleural effusion, and asymptomatic (pleural
plaques present)
- No prior exposure to asbestos but with benign pleural effusion
- Tissue obtained by pleuroscopy, surgical biopsy, or video-thoracoscopy available
- Paraffin-embedded and frozen tissue available
Exclusion criteria:
- Solitary fibrous tumor
- Diffuse pleural fibrosis
- Purulent pleurisy
PATIENT CHARACTERISTICS:
- Not specified
PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Cancer
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Malignant Mesothelioma
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Intervention(s)
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Other: laboratory biomarker analysis
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Procedure: study of high risk factors
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Primary Outcome(s)
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Mesothelin and osteopontin concentrations in serum
[Time Frame: No]
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Secondary Outcome(s)
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Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression
[Time Frame: No]
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Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples
[Time Frame: No]
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Role of SV40
[Time Frame: No]
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Secondary ID(s)
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CDR0000564050
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INCA-05-145
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INCA-RECF0433
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INCA-Mesothel
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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