Onderzoek naar de gevoeligheid van tumorcellen uit pleuravocht voor verschillende chemotherapeutische middelen bij patiënten met een niet-kleincellig longcarcinoom of mesothelioom

• Conditions: Malignant pleural mesothelioma or metastatic NSCLCMaligne longvlieskanker of uitgezaaide longkanker (NSCLC)

• Registration Number: NL-OMON28874
• Lead Sponsor: Stichting Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

/A

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

• Patients with histologically or cytologically proven malignant mesothelioma or non-small cell lung cancer that have a pleural effusion.

• Age >18 years.

Exclusion Criteria

• Active uncontrolled infection, severe cardiac dysfunction or non-correctable bleeding tendency.

• Any identification of a driver mutation for which a registered treatment is available

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The primary endpoint is accuracy of the drug profiling method, defined by the number of truly predicted responses, as a percentage of the total number of patients in the study.

Secondary Outcome Measures

Name	Time	Method
Secondary endpoints include objective response rates (ORR), progression free survival (PFS), overall survival (OS), pulmonary function and frequency and severity of adverse events. <br /><br>Exploratory endpoints to identify potential biomarkers include genomic profiling and assessment of the accuracy of response evaluation by breath prints of Volatile Organic Compounds by SpiroNose.