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

Plain-language summary

This study examines the value of circulating tumor DNA (ctDNA) in the blood for predicting outcomes in patients with resectable stage IIIA non-small cell lung cancer who receive neoadjuvant treatment before surgery. Previously untreated patients aged 18 and older whose tumors are considered operable were included. The study has no assigned phase and is currently active but not recruiting new participants.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

N/A

Status

Active, not recruiting

Sponsor

Fundación GECP

Start date

6/17/2022

Estimated completion

12/30/2027

Countries

Spain

Related genes

Locations

• A Coruña, Spain
• Alicante, Spain
• Badalona, Spain
• Barcelona, Spain
• Barcelona, Spain
• Bilbao, Spain
• Córdoba, Spain
• Girona, Spain
• Pamplona, Spain
• Jaén, Spain
• Lugo, Spain
• Madrid, Spain
• Madrid, Spain
• Madrid, Spain
• Majadahonda, Spain
• Málaga, Spain
• Palma de Mallorca, Spain
• Valencia, Spain
• Valencia, Spain
• Valladolid, Spain

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.