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Tumor cells in pleural effusion and peripheral blood of malignant pleural mesothelioma patients


- candidate number17644
- NTR NumberNTR4575
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-mei-2014
- Secondary IDsNL47437.078.14 Erasmus MC MEC-2014-116
- Public TitleTumor cells in pleural effusion and peripheral blood of malignant pleural mesothelioma patients
- Scientific TitleTumor cells in pleural effusion and peripheral blood of malignant pleural mesothelioma patients
- ACRONYMMESOPA
- hypothesisWe hypothesize that the use of a modified CellSearch enrichment method will specifically detect MPM tumor cells in the pleural effusion and peripheral blood of patients with MPM
- Healt Condition(s) or Problem(s) studiedMesothelioma, Circulating tumor cells
- Inclusion criteria- Age ≥ 18 years
- Patient requiring a pleural drainage or VATS as a part of standard care
- High clinical suspicion of the presence of pleural effusion
- Written informed consent
- Exclusion criteriaNone
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- groupParallel
- Type2 or more arms, non-randomized
- Studytypeobservational
- planned startdate 1-mei-2014
- planned closingdate1-dec-2017
- Target number of participants60
- Interventions1) blood collection for circulating tumor cell enumeration, circulating endothelial cell enumeration and immune cell analysis
2) pleural effusion collection for pleural effusion tumor cell analysis
(NB these are not formal interventions, since they are being performed as a part of standard clinical practice)
- Primary outcomeTo investigate the use of a modified CellSearch enrichment for the enumeration of pleural effusion tumor cells (PTCs) to increase sensitivity of pleural effusion evaluation in malignant pleural mesothelioma (MPM) as compared to standard cytological analysis by the pathologist
- Secondary outcome- To investigate the presence of circulating tumor cells (CTCs) in MPM patients and its correlation with the presence of PTCs
- To indisputably confirm that PTCs in patients with MPM indeed represent MPM cells
- To investigate the presence of tumor-derived circulating endothelial cells in MPM patients
- To develop a flow cytometric method for the enumeration of PTCs in MPM patients
- To investigate whether the number of PTCs, CTCs, CECs or immune cells is a prognostic marker for overall survival in MPM patients
- To explore the occurrence of immune suppressive cells (e.g. regulatory T-cells and MDSC) and associated cytokines in the peripheral blood of MPM patients and their correlation with the occurrence of CTC
- TimepointsBaseline: blood draw and pleural effusion punction
Follow-up: follow-up of overall survival up to 2.5 year following baseline
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD N. Beije
- CONTACT for SCIENTIFIC QUERIESMD N. Beije
- Sponsor/Initiator Erasmus Medical Center, Daniel den Hoed Cancer Center
- Funding
(Source(s) of Monetary or Material Support)
Erasmus Medical Center, Daniel den Hoed Cancer Center
- Publications
- Brief summaryMalignant pleural mesothelioma (MPM) is an aggressive and treatment-resistant neoplasm that is often asbestosis-induced. Patients suffering from MPM often present with pleural effusions. Currently, no biomarker is available with an accuracy that is clinically acceptable to either confirm or exclude the diagnosis malignant mesothelioma, based on pleural effusion cytology. Therefore, thoracoscopy is still the golden standard for diagnosing MPM. A thoracoscopy is an invasive procedure associated with morbidity (amongst which hospitalisation, pain, cardiac rhythm problems) and even with adequate tissue it can be difficult to conclusively identify MPM. We hypothesize that the use of a modified CellSearch enrichment method will specifically detect MPM tumor cells in the pleural effusion and peripheral blood of patients with MPM. By using this approach, we aim to increase the sensitivity of fluid cytology of pleural effusion in MPM as well as to explore the use of circulating biomarkers in peripheral blood of MPM patients, thereby contributing to a better diagnosis of MPM and hopefully a better outcome for patients.
- Main changes (audit trail)
- RECORD2-mei-2014 - 1-jun-2014


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