Ireland
--:--IST
Active, not recruiting Observational

Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment

NCT05382052 · tracked via the Priya Life Science Spain tracker
Phase
Observational
Started
2022-06-17
Last updated
2025-11-19

Condition(s) studied

Non Small Cell Lung Cancer Stage IIINeoadjuvant Treatment

Study summary

This is an observational, prospective, multicentre and nationwide study.

The study enroll resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.

The primary objective of this study is evaluating whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 1\. Previously untreated patients with histologically- or cytologically- documented NSCLC who present stage IIIA disease (according to 8th version of the International Association for the Study of Lung Cancer Staging Manual in Thoracic Oncology) and also, potentially resectable locally advanced NSCLC patients' stage IIIB with T3N2 disease according to 8th edition can be included. * 2\. Tumor should be considered resectable before study entry by a multidisciplinary team * 3\. ECOG 0-1 * 4\. Age ≥ 18 years at time of study entry * 5\. Patients that are going to be treated with neoadjuvant treatment before surgery * 6\. Patient capable of proper therapeutic compliance and accessible for correct follow-up * 7\. Patients must have signed, dated and IRB/EC-approved written informed consent form in accordance with regulatory and institutional guidelines. This must be obtained before the performance of any protocol-related procedures that are not part of normal subject care. Exclusion Criteria: * 1\. Patients who refuse to sign and date an IRB/IEC-approved written informed consent form. * 2\. No possibility of venipuncture * 3\. Any medical, mental, or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information.

Primary outcome measure(s)

  • To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS). — From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months
    To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and PFS

Trial sites (20)

FacilityCityRegionStatus
Hospital Universitario De A Coruna A Coruña A Coruña
Hospital General Universitario de Alicante Alicante Alicante
Hospital Germans Trias I Pujol Badalona Barcelona
Hospital Universitari Quiron Dexeus Barcelona Barcelona
Hospital Universitari Vall d' Hebron Barcelona Barcelona
Hospital De Basurto Bilbao Bilbao
Hospital Universitario Reina Sofia Córdoba Córdoba
ICO Girona, Hospital Josep Trueta Girona Girona
Complejo Hospitalario de Navarra Pamplona Iruña
Hospital Universitario de Jaén Jaén Jaén
Hospital Universitario Lucus Augusti Lugo Lugo
Hospital Clínico San Carlos Madrid Madrid
Hospital Universitario Fundación Jiménez Díaz Madrid Madrid
Hospital Universitario la Paz Madrid Madrid
Hospital Universitario Puerta de Hierro Majadahonda Madrid
Hospital Universitario Regional de Málaga Málaga Málaga
Hospital Universitari Son Llatzer Palma de Mallorca Palma de Mallorca
Hospital Clínico de Valencia Valencia Valencia
Hospital Universitario La Fe Valencia Valencia
Hospital Clínico Universitario de Valladolid Valladolid Valladolid
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05382052 on ClinicalTrials.gov ↗ ← All trials in Spain