Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
Status: Recruiting
Location: See all (20) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
Spain
Hospital Universitario De A Coruna
RECRUITING
A Coruña
Hospital General Universitario de Alicante
RECRUITING
Alicante
Hospital Germans Trias I Pujol
RECRUITING
Badalona
Hospital Universitari Quiron Dexeus
RECRUITING
Barcelona
Hospital Universitari Vall d' Hebron
RECRUITING
Barcelona
Hospital De Basurto
RECRUITING
Bilbao
Hospital Universitario Reina Sofia
RECRUITING
Córdoba
ICO Girona, Hospital Josep Trueta
RECRUITING
Girona
Hospital Universitario de Jaén
RECRUITING
Jaén
Hospital Universitario Lucus Augusti
RECRUITING
Lugo
Hospital Clínico San Carlos
RECRUITING
Madrid
Hospital Universitario Fundación Jiménez Díaz
RECRUITING
Madrid
Hospital Universitario la Paz
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro
RECRUITING
Majadahonda
Hospital Universitario Regional de Málaga
RECRUITING
Málaga
Hospital Universitari Son Llatzer
RECRUITING
Palma De Mallorca
Complejo Hospitalario de Navarra
RECRUITING
Pamplona
Hospital Clínico de Valencia
RECRUITING
Valencia
Hospital Universitario La Fe
RECRUITING
Valencia
Hospital Clínico Universitario de Valladolid
RECRUITING
Valladolid
Contact Information
Primary
Eva Pereira
gecp@gecp.org
+34934302006
Time Frame
Start Date:2022-06-17
Estimated Completion Date:2027-12-30
Participants
Target number of participants:100
Treatments
Study group
The study is based on a blood sample analysis in stage IIIA non-small lung cancer patients that are going to receive neoadjuvant treatment in the real world. The patients participating in this non-interventional study will not receive treatment in relation to the study. Prospective information about treatment after neoadjuvant treatment and after the last blood extraction will not be collected.