Impact of Liquid Biopsy on the Therapeutic Pathway for Lung Cancer: Advancing the Molecular Characterization of Patients With Advanced Lung Adenocarcinoma by Integrating Liquid Biopsy Into the Early Stages of the Diagnostic and Therapeutic Pathway
Recruiting · NCT07649629 · Observational (researchers observe without assigning treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
This multicenter pilot observational study aims to assess the feasibility of introducing liquid biopsy at an early stage of the diagnostic pathway for patients with suspected advanced non-small cell lung cancer (NSCLC). Liquid biopsy is a minimally invasive blood test that can detect tumor-related genetic alterations in circulating nucleic acids. The study will evaluate whether this approach can provide molecular information more rapidly than standard tissue-based testing and how closely the results obtained from blood samples match those obtained from tumor tissue. Approximately 70 adult patients with radiological evidence of locally advanced or metastatic lung cancer will be enrolled. Participants will undergo a blood draw for liquid biopsy and will continue to follow the standard diagnostic pathway, including tissue biopsy or cytological sampling when indicated. The results generated within the study are intended for research purposes and will not replace standard diagnostic procedures or independently determine treatment decisions. The findings will be used to identify practical and methodological issues and to support the design of future clinical studies on the plasma-first approach.
Who can take part
Inclusion criteria
- Age ≥ 18 years.
- Radiological suspicion of locally advanced lung cancer not amenable to locoregional treatment or metastatic lung cancer (stage III-IV).
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1.
- Tissue biopsy and/or cytological sampling planned but not yet performed, or already performed without an available histopathological diagnosis of non-small cell lung cancer (NSCLC).
- Written informed consent for study participation and personal data processing obtained before any study-specific procedure.
Exclusion criteria
- Previous or current history of non-small cell lung cancer (NSCLC).
- Histopathological diagnosis of NSCLC already available following tissue biopsy.
- Eligibility for surgical removal of tumor tissue.
- Ongoing or previous systemic oncological treatment for lung cancer.
Where it is running
1 location listed.
- IFO-IRE, Istituto Nazionale Tumori Regina Elena - Roma, RM, Italy