Evaluating ctDNA as a Prognostic Factor in Stage IIIA Lung Cancer Patients
Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
This study is testing if measuring tumor DNA in the blood can help predict how long people with stage IIIA lung cancer will stay cancer-free after their treatment before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación GECP Academic / other |
| Locations | 20 sites (Badalona, Barcelona and 19 other locations) |
| Trial ID | NCT05382052 on ClinicalTrials.gov |
What this trial studies
This observational, multicenter study aims to enroll approximately 100 patients with resectable stage IIIA non-small cell lung cancer (NSCLC) who will receive neoadjuvant treatment. The primary goal is to assess the relationship between the clearance of circulating tumor DNA (ctDNA) after neoadjuvant treatment and progression-free survival before surgery. Blood samples will be collected at five different time points, and patient data will be monitored without interfering with standard clinical practices. The study will follow participants for 36 months post-surgery to evaluate the prognostic significance of ctDNA.
Who should consider this trial
Good fit: Ideal candidates include previously untreated adults aged 18 and older with histologically confirmed resectable stage IIIA NSCLC who are scheduled for neoadjuvant treatment.
Not a fit: Patients with non-resectable lung cancer or those who are not candidates for neoadjuvant treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new prognostic marker for predicting outcomes in patients with stage IIIA NSCLC.
How similar studies have performed: While the use of ctDNA as a prognostic factor is gaining traction, this specific approach in the context of resectable stage IIIA NSCLC is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Badalona, Barcelona and 19 other locations
- Hospital Germans Trias I Pujol — Badalona, Barcelona, Spain (Recruiting)
- Complejo Hospitalario de Navarra — Pamplona, Iruña, Spain (Recruiting)
- Hospital Universitario Puerta de Hierro — Majadahonda, Madrid, Spain (Recruiting)
- Hospital Universitario De A Coruna — A Coruña, Spain (Recruiting)
- Hospital General Universitario de Alicante — Alicante, Spain (Recruiting)
- Hospital Universitari Quiron Dexeus — Barcelona, Spain (Recruiting)
- Hospital Universitari Vall d' Hebron — Barcelona, Spain (Recruiting)
- Hospital De Basurto — Bilbao, Spain (Recruiting)
- Hospital Universitario Reina Sofia — Córdoba, Spain (Recruiting)
- ICO Girona, Hospital Josep Trueta — Girona, Spain (Recruiting)
- Hospital Universitario de Jaén — Jaén, Spain (Recruiting)
- Hospital Universitario Lucus Augusti — Lugo, Spain (Recruiting)
- Hospital Clínico San Carlos — Madrid, Spain (Recruiting)
- Hospital Universitario Fundación Jiménez Díaz — Madrid, Spain (Recruiting)
- Hospital Universitario la Paz — Madrid, Spain (Recruiting)
- Hospital Universitario Regional de Málaga — Málaga, Spain (Recruiting)
- Hospital Universitari Son Llatzer — Palma De Mallorca, Spain (Recruiting)
- Hospital Clínico de Valencia — Valencia, Spain (Recruiting)
- Hospital Universitario La Fe — Valencia, Spain (Recruiting)
- Hospital Clínico Universitario de Valladolid — Valladolid, Spain (Recruiting)
Study contacts
- Study coordinator: Eva Pereira
- Email: gecp@gecp.org
- Phone: +34934302006
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.