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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and progression free survival (PFS). | To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and PFS | From date of end of neoadjuvant treatment and before surgery until the date of progression free survival, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate whether there is a significant association between ctDNA clearance after neoadjuvant treatment and before surgery and overall survival. | To assess the association between the baseline ctDNA and ctDNA clearance with each one of the three outcomes: after neoadjuvant treatment, before surgery and Overall Survival | From date of end of neoadjuvant treatment and before surgery until the date of death, assessed up to 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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Resectable stage IIIA non-small cell lung cancer patients that are going to receive neoadjuvant treatment in real world.
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| Name | Affiliation | Role |
|---|---|---|
| Mariano Provencio, MD | President of Grupo Español de Cáncer de Pulmón | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario De A Coruna | A Coruña | A Coruña | 15006 | Spain | ||
| Hospital General Universitario de Alicante |
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| Label | URL |
|---|---|
| Description Web page of the sponsor where users can find more information about Fundacion GECP studies. | View source |
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Five blood samples per patient will be collected:
The blood samples (5-10 ml each) will be collected in two Cell-Free DNA BCT tube and two PTT EDTA K2.
These samples will be sent to the central laboratory the same day of extraction at room temperature.
ctDNA will be extracted using the QIAamp Circulating Nucleic Acid Kit. NGS analysis of ctDNA will be performed using a panel that will target at least of 1.5 Mb and will include genes of interest.
| To evaluate whether there is a significant association between ctDNA clearance and pathological complete response or major pathologic response. | To assess the association between the baseline ctDNA and ctDNA clearance with each one of the two outcomes: after complete response or major pathologic response (MPR). | From the end of neoadjuvant treatment and before surgery until the death of complete response or MPR, assessed up to 24 months |
| To identify somatic mutations in ctDNA that predispose to a better/worse overall survival | To identify somatic mutations in ctDNA in the pre-treatment plasma that predispose to a better/worse overall survival. | From the date of extraction of blood in pretreatment period until the date of major pathologic response or death, assessed up to 24 months |
| Alicante |
| Alicante |
| 03010 |
| Spain |
| Hospital Germans Trias I Pujol | Badalona | Barcelona | 08916 | Spain |
| Hospital Universitari Quiron Dexeus | Barcelona | Barcelona | 08028 | Spain |
| Hospital Universitari Vall d' Hebron | Barcelona | Barcelona | 08035 | Spain |
| Hospital De Basurto | Bilbao | Bilbao | 48013 | Spain |
| Hospital Universitario Reina Sofia | Córdoba | Córdoba | 14004 | Spain |
| ICO Girona, Hospital Josep Trueta | Girona | Girona | 17007 | Spain |
| Complejo Hospitalario de Navarra | Pamplona | Iruña | 31008 | Spain |
| Hospital Universitario de Jaén | Jaén | Jaén | 23007 | Spain |
| Hospital Universitario Lucus Augusti | Lugo | Lugo | 27003 | Spain |
| Hospital Clínico San Carlos | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario Fundación Jiménez Díaz | Madrid | Madrid | 28040 | Spain |
| Hospital Universitario la Paz | Madrid | Madrid | 28046 | Spain |
| Hospital Universitario Puerta de Hierro | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario Regional de Málaga | Málaga | Málaga | 29010 | Spain |
| Hospital Universitari Son Llatzer | Palma de Mallorca | Palma de Mallorca | 07198 | Spain |
| Hospital Clínico de Valencia | Valencia | Valencia | 46010 | Spain |
| Hospital Universitario La Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Clínico Universitario de Valladolid | Valladolid | Valladolid | 47003 | Spain |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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