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Spots Global Cancer Trial Database for Study of ctDNA as Prognostic Factor on Resectable Stage IIIA NSCLC Patients Treated With Neoadjuvant Treatment

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Trial Identification

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

Interventions

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Mariano Provencio, MD

Affiliation: President of Grupo Español de Cáncer de Pulmón

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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