Clinical trial · Observational
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
Impatto Della Biopsia Liquida Sul Percorso Terapeutico Del Tumore al Polmone: Anticipare la Caratterizzazione Molecolare Dei Pazienti Con Adenocarcinoma Del Polmone in Stadio Avanzato Integrando la Biopsia Liquida Nella Fase Iniziale Del Percorso Diagnostico-terapeutico
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Non-small Cell Lung Cancer (NSCLC) | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Plasma-based liquid biopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Prospective Plasma-First NSCLC Cohort
- description
- Adult patients with radiological suspicion of locally advanced non-small cell lung cancer (NSCLC) not suitable for locoregional treatment, or metastatic NSCLC, will be enrolled before completion of the standard diagnostic pathway. Participants will undergo a peripheral blood draw for liquid biopsy within one week of the first clinical assessment. Plasma-derived circulating nucleic acids will be analyzed using next-generation sequencing (NGS) to evaluate molecular alterations, turnaround time, concordance with tissue-based profiling, and tumor fraction. All participants will continue the standard diagnostic pathway of the enrolling center, including tissue biopsy or cytological sampling, histopathological diagnosis, PD-L1 assessment, and tissue-based molecular testing. No investigational treatment is assigned, and study procedures will not independently determine treatment decisions.
- interventionNames
- Diagnostic Test: Plasma-based liquid biopsy
Primary outcomes (1)
- measure
- Feasibility of establishing a structured plasma-first molecular profiling dataset
- timeFrame
- Up to 18 months
- description
- Proportion of enrolled participants with a complete structured dataset including liquid biopsy results, tissue-based diagnostic and molecular profiling results, and relevant clinical data required for the feasibility assessment of the plasma-first approach.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (4)
- BACKGROUNDLow SK, Ariyasu R, Uchibori K, Hayashi R, Chan HT, Chin YM, Akita T, Harutani Y, Kiritani A, Tsugitomi R, Manabe R, Ogusu S, Amino Y, Kitazono S, Yanagitani N, Nakamura Y, Nishio M. Rapid genomic profiling of circulating tumor DNA in non-small cell lung cancer using Oncomine Precision Assay with Genexus integrated sequencer. Transl Lung Cancer Res. 2022 May;11(5):711-721. doi: 10.21037/tlcr-21-981. PMID 35693289
- BACKGROUNDHusain H, Pavlick DC, Fendler BJ, Madison RW, Decker B, Gjoerup O, Parachoniak CA, McLaughlin-Drubin M, Erlich RL, Schrock AB, Frampton GM, Das Thakur M, Oxnard GR, Tukachinsky H. Tumor Fraction Correlates With Detection of Actionable Variants Across > 23,000 Circulating Tumor DNA Samples. JCO Precis Oncol. 2022 Oct;6:e2200261. doi: 10.1200/PO.22.00261. PMID 36265119
- BACKGROUNDRolfo C, Mack P, Scagliotti GV, Aggarwal C, Arcila ME, Barlesi F, Bivona T, Diehn M, Dive C, Dziadziuszko R, Leighl N, Malapelle U, Mok T, Peled N, Raez LE, Sequist L, Sholl L, Swanton C, Abbosh C, Tan D, Wakelee H, Wistuba I, Bunn R, Freeman-Daily J, Wynes M, Belani C, Mitsudomi T, Gandara D. Liquid Biopsy for Advanced NSCLC: A Consensus Statement From the International Association for the Study of Lung Cancer. J Thorac Oncol. 2021 Oct;16(10):1647-1662. doi: 10.1016/j.jtho.2021.06.017. Epub 2021 Jul 8. PMID 34246791
- BACKGROUNDGarcia-Pardo M, Czarnecka K, Law JH, Salvarrey A, Fernandes R, Fan J, Corke L, Waddell TK, Yasufuku K, Donahoe LL, Pierre A, Le LW, Ghumman N, Liu G, Shepherd FA, Bradbury P, Sacher A, Stockley T, Pal P, Rogalla P, Tsao MS, Leighl NB. Plasma-first: accelerating lung cancer diagnosis and molecular profiling through liquid biopsy. Ther Adv Med Oncol. 2022 Sep 20;14:17588359221126151. doi: 10.1177/17588359221126151. eCollection 2022. PMID 36158638