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Voorspellende waarde van soluble mesothelin-related peptide, CEA, Cyfra 21-1 and CA 125 bij patiŽnten met pleuravocht.


- candidate number8123
- NTR NumberNTR2361
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR7-jun-2010
- Secondary IDsP10-11 METC MST Enschede
- Public TitleVoorspellende waarde van soluble mesothelin-related peptide, CEA, Cyfra 21-1 and CA 125 bij patiŽnten met pleuravocht.
- Scientific TitleDiagnostic value of soluble mesothelin-related peptide (SMRP), CEA, CA125 and CYFRA 21-1 for malignancy in pleural fluid, the mesothelin study.
- ACRONYM
- hypothesisEstablishing the cause of pleural disease often is a great challenge. Definitive diagnosis of pleural disease needs histological confirmation in most cases. Clinical suspicion of malignancy often indicates prompt use of invasive procedures like thoracoscopy. In the case of elderly and or disabled patients it is often worthwhile to have clinical arguments to decide whether thoracoscopy should be part of the diagnostic procedures. Therefore additional information about the underlying disease causing pleural abnormalities is often valuable. It might be usefull to add the predictive value of tumour markers in serum and pleural fluid in this diagnostic process.
- Healt Condition(s) or Problem(s) studiedPleural fluid, Mesothelin, Tumormarkers
- Inclusion criteria1. Pleural fluid;
2. Age over 18 years;
3. Clinical indication for analysing pleural fluid.
- Exclusion criteria1. Known cause of the pleural fluid;
2. Clinical and/or radiological suspicion for pleural empyema;
3. Malignancy in the 2 years before presentation.
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 1-aug-2010
- planned closingdate1-feb-2012
- Target number of participants120
- Interventions1. Thoracentesis;
2. Venapuncture.
- Primary outcomeTo test the diagnostic capacity for malignancy in pleural fluid of the tumour markers SMRP, CEA, Cyfra 21-1 and Ca 125 by patients presenting with pleural fluid without any known or suspected cause.
- Secondary outcomeThe prognostic capacity of the same markers in malignant pleural disease.
- Timepoints1. Diagnostic capacity, timepoint: 0 and 3 months;
2. Prognostic capacity, timepoint: 1 1/2 year.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. J.H. Schouwink
- CONTACT for SCIENTIFIC QUERIESDr. J.H. Schouwink
- Sponsor/Initiator Medisch Spectrum Twente, Ziekenhuisgroep Twente
- Funding
(Source(s) of Monetary or Material Support)
Medisch Spectrum Twente, Enschede, Ziekenhuisgroep Twente
- PublicationsN/A
- Brief summaryRationale:
Establishing the cause of pleural disease often is a great challenge. Definitive diagnosis of pleural disease needs histological confirmation in most cases. Clinical suspicion of malignancy often indicates prompt use of invasive procedures like thoracoscopy. In the case of elderly and or disabled patients it is often worthwhile to have clinical arguments to decide whether thoracoscopy should be part of the diagnostic procedures. Therefore additional information about the underlying disease causing pleural abnormalities is often valuable.

Study title:
The predictive value of tumour marker in serum and pleural fluid.

Main investigators:
Dr J.H. Schouwink, mevr dr. Ir. L. Mulder, H. Sinnighe Damste, O. Akkerman.

Purpose of the study:
Primary, to test the diagnostic capacity of the tumour markers SMRP, CEA, Cyfra 21-1 and Ca 125 differentiating malignant from benign disease. Secondly, the prognostic value of the same markers in malignant pleural disease.

Population:
Patients, aged over 18 years, with pleural fluid at presentation in the outpatient clinic. The pleural fluid needs further analysis. Excluded will be all patients with a known cause of the pleural fluid. Patients with a pleural empyema (clinically or radiologically) or all patients with a treated malignancy in the 2 years before presentation are excluded.

Study design:
This study is a multi-centre cohort trial in patients with pleural effusion without any known cause or evidentially expected cause.
All patients will have thoracocentesis at presentation and if possible after 3 months. We will also collect serum at the same time. Also other baseline characteristics with a proven prognostic value for MPM will be collected, (i.e. Karnofsky score, pain at presentation, thrombocyte count).

Outcome measures:
Primary, to test the diagnostic capacity for malignancy in pleural fluid of the tumour markers SMRP, CEA, Cyfra 21-1 and Ca 125 by patients presenting with pleural fluid without any known or suspected cause. Secondly, the prognostic value of the same markers in malignant pleural fluid.
- Main changes (audit trail)
- RECORD7-jun-2010 - 20-jun-2010


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