NCT07649629Recruiting
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 · Last updated 16 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 70 (estimated)
- First submitted
- 4 Jun 2026
- Start date
- 1 Sept 2025
- Primary completion date
- 1 Mar 2027
- Lead sponsor
- Regina Elena Cancer Institute
- Diseases
- Lung cancer
- NCT number
- NCT07649629
What you commit to
- Study type: Observational
- Planned participants: 70
- From 1 Sept 2025 to the primary completion date, 1 Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current history of non-small cell lung cancer (NSCLC).
- Eligibility for surgical removal of tumor tissue.
- Ongoing or previous systemic oncological treatment for lung cancer.
Other
- Histopathological diagnosis of NSCLC already available following tissue biopsy.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| IFO-IRE, Istituto Nazionale Tumori Regina Elena Coordinator of this site? Confirm its status | Roma | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.