NCT07649629 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
| NCT ID | NCT07649629 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Regina Elena Cancer Institute |
| Condition | Advanced Non-small Cell Lung Cancer (NSCLC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-09-01 |
| Primary Completion | 2027-03-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 70 participants in total. It began in 2025-09-01 with a primary completion date of 2027-03-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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.
Contact & Investigator
Federico Cappuzzo, MD
PRINCIPAL INVESTIGATOR
IFO-IRE, Istituto Nazionale Tumori Regina Elena
Frequently Asked Questions
Who can join the NCT07649629 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Advanced Non-small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07649629 currently recruiting?
Yes, NCT07649629 is actively recruiting participants. Contact the research team at maristella.giammaruco@ifo.it for enrollment information.
Where is the NCT07649629 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07649629 clinical trial?
NCT07649629 is sponsored by Regina Elena Cancer Institute. The principal investigator is Federico Cappuzzo, MD at IFO-IRE, Istituto Nazionale Tumori Regina Elena. The trial plans to enroll 70 participants.
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