No registrations found.
ID
Source
Brief title
Health condition
Malignant pleural mesothelioma
Mesothelioma
Pleural effusion tumor cells
Circulating tumor cells
Circulating endothelial cells
Asbestkanker
Maligne pleuraal mesothelioom
Sponsors and support
Intervention
Outcome measures
Primary outcome
To 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
Background summary
Malignant 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.
Study objective
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
Study design
Baseline: blood draw and pleural effusion punction
Follow-up: follow-up of overall survival up to 2.5 year following baseline
Intervention
1) 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)
Department of Medical Oncology
's Gravendijkwal 230
N. Beije
Rotterdam 3015 CE
The Netherlands
n.beije@erasmusmc.nl
Department of Medical Oncology
's Gravendijkwal 230
N. Beije
Rotterdam 3015 CE
The Netherlands
n.beije@erasmusmc.nl
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 criteria
None
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4452 |
| NTR-old | NTR4575 |
| CCMO | NL47437.078.14 |
| OMON | NL-OMON40425 |