Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia
Recruitment status was Recruiting
RATIONALE: Studying levels of mesothelin and osteopontin in samples of blood from patients with mesothelioma or atypical mesothelial hyperplasia may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at mesothelin and osteopontin as diagnostic markers in patients with mesothelioma or atypical hyperplasia.
Other: laboratory biomarker analysis
Procedure: study of high risk factors
|Official Title:||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.|
- Mesothelin and osteopontin concentrations in serum [ Designated as safety issue: No ]
- Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples [ Designated as safety issue: No ]
- Role of SV40 [ Designated as safety issue: No ]
- Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression [ Designated as safety issue: No ]
|Study Start Date:||April 2007|
|Estimated Primary Completion Date:||January 2010 (Final data collection date for primary outcome measure)|
- Determine if mesothelin and osteopontin in serum can serve as early markers of malignant transformation into mesothelioma.
- Determine if there are cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples.
- Determine if SV40 has a carcinogenic role.
- Determine the relationship between the serum concentration of mesothelin and/or osteopontin and the expression of other markers and with clinical progression.
OUTLINE: This is a multicenter study.
Levels of mesothelin and osteopontin in serum (and pleural fluid, if effusion is present) are measured at baseline and 3, 6, 12, and 24 months. Patients with mesothelioma, reactional lesions, or adenocarcinoma undergo tomodensitometry (TDM) at baseline, 3, 6, and 12 months. Patients with pleural plaques only undergo TDM at 12 months.
Patients are followed for 5 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00899613
|CHU de Caen||Recruiting|
|Caen, France, 14033|
|Contact: Francoise Galateau-Salle 33-231-064-923|
|Investigator:||Francoise Galateau-Salle||University Hospital, Caen|