Malignant MesotheliomaNCT00899613
Mesothelin and Osteopontin as Diagnostic Markers in Patients With Mesothelioma or Atypical Mesothelial Hyperplasia
An observational study of Malignant Mesothelioma and Metastatic Cancer, run by University Hospital, Caen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Malignant Mesothelioma, Metastatic Cancer
- What is being tested?
- laboratory biomarker analysis and study of high risk factors
- Type of treatment
- Surgery or procedure
- How many people
- 270 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jan 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Solitary fibrous tumor
- Diffuse pleural fibrosis
- Purulent pleurisy
- PATIENT CHARACTERISTICS:
- Not specified
- PRIOR CONCURRENT THERAPY:
- No prior chemotherapy or radiotherapy
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
CHU de Caen
Caen, 14033
Francoise Galateau-Salle, 33-231-064-923
About this study
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.
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.
Read the 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.
- Conditions
- Malignant Mesothelioma, Metastatic Cancer
- Being tested
- laboratory biomarker analysis, study of high risk factors
- Keywords
- localized malignant mesothelioma, lung metastases, malignant pleural effusion
- Medical subject headings
- Mesothelioma, Malignant, Neoplasm Metastasis, Pleural Effusion, Malignant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
study of high risk factorsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesothelin and osteopontin concentrations in serum
Secondary outcomes (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2007
- Primary completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant MesotheliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, CaenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Investigators
- Francoise Galateau-Salle, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00899613
- Sponsor's protocol ID
- CDR0000564050
- Other IDs
- INCA-RECF0433, INCA-05-145, INCA-Mesothel
- Status last verified
- Jul 2009
- First submitted
- 9 May 2009
- Last updated
- 15 Dec 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT00899613
- Acronym / sponsor ID
- CDR0000564050
- Conditions
- Malignant Mesothelioma, Metastatic Cancer
- Keywords
- localized malignant mesothelioma, lung metastases, malignant pleural effusion
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Jan 2010 (estimated)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Diagnosis of mesothelial hyperplasia and meeting 1 of the following criteria:
- Tissue obtained by pleuroscopy, surgical biopsy, or video-thoracoscopy available
Key exclusion criteria (7 listed)
- Solitary fibrous tumor
- Diffuse pleural fibrosis
- Purulent pleurisy
- Not specified
- No prior chemotherapy or radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| study of high risk factors | Procedure or surgery | – |
Primary outcome
Mesothelin and osteopontin concentrations in serum
3 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Francoise Galateau-Salle
University Hospital, Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Malignant Mesothelioma and Metastatic Cancer, run by University Hospital, Caen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesothelin and osteopontin concentrations in serum. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2009.