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

RECRUITINGSponsored by Catharina Ziekenhuis Eindhoven
Actively Recruiting
SponsorCatharina Ziekenhuis Eindhoven
Started2023-10-31
Est. completion2026-10
Eligibility
Age18 Years+
Healthy vol.Accepted

Summary

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* Aged 18 or above and suspected of having lung cancer

Exclusion Criteria:

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

Conditions2

CancerLung Cancer

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