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Brief Title: Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
Official Title: Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment
Study ID: NCT05382052
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 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.
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 collection of blood samples at five times and patient data, it does not entail any diagnostic or therapeutic procedure outside of normal clinical practice. Approximately 100 resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world will be recruited for this study in Spain. With this figure, it can be estimated whether ctDNA, both baseline and its negativization, has a role as a prognostic marker in the evolution of these patients in real-life conditions. The primary objective of this study is evaluate whether there is a significant association between ctDNA clearance (no detection of ctDNA) after neoadjuvant treatment and before surgery and progression free survival. The study is planned with the recruitment of patients over a year to a follow-up of 36 months post-surgery.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Hospital Germans Trias I Pujol, Badalona, Barcelona, Spain
Complejo Hospitalario de Navarra, Pamplona, Iruña, Spain
Hospital Universitario Puerta de Hierro, Majadahonda, Madrid, Spain
Hospital Universitario De A Coruna, A Coruña, , Spain
Hospital General Universitario de Alicante, Alicante, , Spain
Hospital Universitari Quiron Dexeus, Barcelona, , Spain
Hospital Universitari Vall d' Hebron, Barcelona, , Spain
Hospital De Basurto, Bilbao, , Spain
Hospital Universitario Reina Sofia, Córdoba, , Spain
ICO Girona, Hospital Josep Trueta, Girona, , Spain
Hospital Universitario de Jaén, Jaén, , Spain
Hospital Universitario Lucus Augusti, Lugo, , Spain
Hospital Clínico San Carlos, Madrid, , Spain
Hospital Universitario Fundación Jiménez Díaz, Madrid, , Spain
Hospital Universitario la Paz, Madrid, , Spain
Hospital Universitario Regional de Málaga, Málaga, , Spain
Hospital Universitari Son Llatzer, Palma De Mallorca, , Spain
Hospital Clínico de Valencia, Valencia, , Spain
Hospital Universitario La Fe, Valencia, , Spain
Hospital Clínico Universitario de Valladolid, Valladolid, , Spain
Name: Mariano Provencio, MD
Affiliation: President of Grupo Español de Cáncer de Pulmón
Role: STUDY_CHAIR