Implementation of Up-front ctDNA Into Lung Cancer Care and Development of Liquid Biopsy-based Decision Support Models - LM² Study

Recruiting now

Conditions studied: Lung Cancer

In brief

Despite scientific evidence, use of liquid biopsy (LB) in diagnosis and monitoring of lung cancer (LC) is limited since it requires major changes in diagnostic and care pathways. Analyzing tumor markers (TMs), circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in blood (LB) can inform about the nature of the tumor, the most appropriate therapy, therapy response and resistance. Lungmarker2 is a multicenter, prospective, implementation and diagnostic cohort study. This study aims to implement up-front ctDNA analysis ('plasma first approach') into routine diagnostic work-up of all advanced stage LC patients in the Southeast of the Netherlands (the participating hospitals in the OncoZON region). Thereby, additional information about the molecular make-up of the tumor becomes available, the number of tissue Next-Generation Sequencing (NGS) analyses will decrease and time to therapeutic decision making is shortened. Next, using ctDNA, TM and other information, multi-parametric decision support models are built and validated that may support diagnosis, predict the outcome of the next imaging procedure and progression-free survival during follow-up. The final goal is to develop a super-resolution microscopy test that can detect PD-L1 expression on CTCs.

Key facts

Study ID

NCT06105177

Run by

Catharina Ziekenhuis Eindhoven

People needed

800

Starts

2023-10-31

Expected to finish

2026-10-01

Last updated by the study team

2024-09-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 or above and suspected of having lung cancer

You may not qualify if…

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

Where it is running

• Catharina Ziekenhuis Eindhoven — Eindhoven, North Brabant, Netherlands (enrolling)
• Zuyderland Medical Center — Heerlen, Limburg, Netherlands
• Maastricht University Medical Center — Maastricht, Limburg, Netherlands
• St. Anna Ziekenhuis — Geldrop, North Brabant, Netherlands
• Máxima Medisch Centrum — Veldhoven, North Brabant, Netherlands

Full record on ClinicalTrials.gov

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