Clincosm LogoSign in Get a demo

Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia

Sponsor
University Hospital, Caen (Other)
Overall Status
Unknown status
CT.gov ID
NCT00899613
Collaborator
(none)
270
Enrollment
1
Location

Study Details

Study Description

Brief Summary

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 Phase
  • Other: laboratory biomarker analysis
  • Procedure: study of high risk factors

Detailed Description

OBJECTIVES:

Primary

  • Determine if mesothelin and osteopontin in serum can serve as early markers of malignant transformation into mesothelioma.

Secondary

  • 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 Design

Study Type:
Observational
Anticipated 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 :
Apr 1, 2007
Anticipated Primary Completion Date :
Jan 1, 2010

Outcome Measures

Primary Outcome Measures

  1. Mesothelin and osteopontin concentrations in serum []

Secondary Outcome Measures

  1. Cytological, histological, immunohistochemical, and molecular markers of precancerous disease in tissue samples []

  2. Role of SV40 []

  3. Relationship of serum concentration of mesothelin and/or osteopontin with the expression of other markers and with clinical progression []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de Caen Caen France 14033

Sponsors and Collaborators

  • University Hospital, Caen

Investigators

  • : Francoise Galateau-Salle, University Hospital, Caen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00899613
Other Study ID Numbers:
  • CDR0000564050
  • INCA-RECF0433
  • INCA-05-145
  • INCA-Mesothel
First Posted:
May 12, 2009
Last Update Posted:
Dec 15, 2009
Last Verified:
Jul 1, 2009
Keywords provided by , ,
localized malignant mesothelioma
lung metastases
malignant pleural effusion
Additional relevant MeSH terms:
Mesothelioma
Mesothelioma, Malignant
Hyperplasia

Study Results

No Results Posted as of Dec 15, 2009