Implementation of up-front ctDNA analysis into lung cancer care and development of liquid biopsy-based decision support models - the Lungmarker2 study

Implementation of up-front ctDNA analysis into lung cancer care and development of liquid biopsy-based decision support models - the Lungmarker2 study - LM2 study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON53764

Enrollment

800

Registered

2023-06-15

Start date

2023-10-31

Completion date

Unknown

Last updated

2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

lung cancer lung carcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: first work-up for suspected lung cancer

Exclusion criteria

Exclusion criteria: Presence of another malignant tumor, i.e. diagnosed with a tumor in the past 5 years

Design outcomes

Primary

Measure	Time frame
ctDNA analysis, as additional source of genetic information, is integrated into the diagnostic workup of LC patients and the medical benefits thereof are quantified, i.e. a significant higher percentage of patients with a driver mutation are identified by the plasma first approach. Multiparametric decision support algorithms based on imaging, TM and ctDNA analyses that identify small-cell LC (SCLC) and non-small-cell LC (NSCLC) are developed and validated. Multiparametric decision support models are developed that enable patient-specific timing of imaging procedures during follow-up of LC patients. A super-resolution microscopy test for PD-L1 is developed and correlation with tumor tissue PD-L1 expression has been established.	—

Measure

Time frame

ctDNA analysis, as additional source of genetic information, is integrated into the diagnostic workup of LC patients and the medical benefits thereof are quantified, i.e. a significant higher percentage of patients with a driver mutation are identified by the plasma first approach. Multiparametric decision support algorithms based on imaging, TM and ctDNA analyses that identify small-cell LC (SCLC) and non-small-cell LC (NSCLC) are developed and validated. Multiparametric decision support models are developed that enable patient-specific timing of imaging procedures during follow-up of LC patients. A super-resolution microscopy test for PD-L1 is developed and correlation with tumor tissue PD-L1 expression has been established.

—

Secondary

Measure	Time frame
An analytical protocol for analysis of PD-L1 expression on CTCs by super-resolution microscopy has been developed. All LC patients with a molecular aberration and all SCLC patients have been followed up by liquid biopsy during treatment. The number of NGS analyses and time to diagnosis decreased by introduction of up-front LB.	—

Countries

Netherlands

Outcome results