Implementation of up-front ctDNA analysis into lung cancer care and development of liquid biopsy-based decision support models - the Lungmarker2 study
Recruiting
- Conditions
- lung cancerlung carcinoma10029107
- Registration Number
- NL-OMON53764
- Lead Sponsor
- Catharina-ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 800
Inclusion Criteria
first work-up for suspected lung cancer
Exclusion Criteria
Presence of another malignant tumor, i.e. diagnosed with a tumor in the past 5
years
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>ctDNA analysis, as additional source of genetic information, is integrated into<br /><br>the diagnostic workup of LC patients and the medical benefits thereof are<br /><br>quantified, i.e. a significant higher percentage of patients with a driver<br /><br>mutation are identified by the plasma first approach. Multiparametric decision<br /><br>support algorithms based on imaging, TM and ctDNA analyses that identify<br /><br>small-cell LC (SCLC) and non-small-cell LC (NSCLC) are developed and validated.<br /><br>Multiparametric decision support models are developed that enable<br /><br>patient-specific timing of imaging procedures during follow-up of LC patients.<br /><br>A super-resolution microscopy test for PD-L1 is developed and correlation with<br /><br>tumor tissue PD-L1 expression has been established.</p><br>
- Secondary Outcome Measures
Name Time Method <p>An analytical protocol for analysis of PD-L1 expression on CTCs by<br /><br>super-resolution microscopy has been developed.<br /><br>All LC patients with a molecular aberration and all SCLC patients have been<br /><br>followed up by liquid biopsy during treatment.<br /><br>The number of NGS analyses and time to diagnosis decreased by introduction of<br /><br>up-front LB.</p><br>