Status:
ACTIVE_NOT_RECRUITING
Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
Lead Sponsor:
Fundación GECP
Conditions:
Non Small Cell Lung Cancer Stage III
Neoadjuvant Treatment
Eligibility:
All Genders
18+ years
Brief 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 ...
Detailed Description
This is an observational, multicenter, one-arm, non-comparative, prospective study that will not under any circumstances interfere in the physician's normal clinical practice. Being limited to the col...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 17 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05382052
Start Date
June 17 2022
End Date
December 30 2027
Last Update
November 19 2025
Active Locations (20)
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1
Hospital Universitario De A Coruna
A Coruña, A Coruña, Spain, 15006
2
Hospital General Universitario de Alicante
Alicante, Alicante, Spain, 03010
3
Hospital Germans Trias I Pujol
Badalona, Barcelona, Spain, 08916
4
Hospital Universitari Quiron Dexeus
Barcelona, Barcelona, Spain, 08028