Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia
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|ClinicalTrials.gov Identifier: NCT00899613|
Recruitment Status : Unknown
Verified July 2009 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : May 12, 2009
Last Update Posted : December 15, 2009
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.
|Condition or disease||Intervention/treatment|
|Malignant Mesothelioma Metastatic Cancer||Other: laboratory biomarker analysis Procedure: study of high risk factors|
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||270 participants|
|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.|
|Study Start Date :||April 2007|
|Estimated Primary Completion Date :||January 2010|
- Mesothelin and osteopontin concentrations in serum
- Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples
- Role of SV40
- Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00899613
|CHU de Caen||Recruiting|
|Caen, France, 14033|
|Contact: Francoise Galateau-Salle 33-231-064-923|
|OverallOfficial:||Francoise Galateau-Salle||University Hospital, Caen|