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Observational, multicentre, retrospective study on patients taken care according to the national guidelines. The objective is to define, after the diagnosis confirmation, the frequency of PD-L1 expression in patients with large-cell lung neuroendocrine carcinoma (NEC), whatever the stage of the disease, and to correlate this parameter to clinical data at the time of diagnosis, therapeutic response and survival. Large-cell NECs present a bad prognostic and there is no evidence of treatment for these patients with advanced disease in second ligne of treatment at that time. To demonstrate the PD-L1 expression in this type of cancer might have a major therapeutic impact in a close future to access immunotherapies.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Immunohistochemistry | Other | The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally. |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC) | Determine the frequency of PD-L1 expression in patients with large-cell neuroendocrine carcinoma (NEC)in terms of percentage of tumor cells expressing PD-L1 in immunohistochemistry (IHC) at the time of diagnosis: The frequency of PD-L1 expression determined by IHC will be as follow:
| Retrospective central evaluation on tumour materials (slides) collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of PD-L1 expression of tumour cells with clinical data | Describe the disease at the time of diagnosis using TNM IASLC/UICC 2009 classification | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 |
| Objective Response Rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients presenting a large-cell NEC taken in charge by investigational centres between January 1st, 2014 and December 31st, 2016.
Alive patients will be identified during disease follow-up visit as per the local current practice and the study will be then proposed to them at that time.
For died patients, eligible patients will be identified by checking the files present at site by the Principal Investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Dominque Arpin, MD | Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier D Argenteuil | Argenteuil | VAL D'oise | 95100 | France | ||
| Site 12 |
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Slides (tumour materials) at diagnosis
Objective Response Rate (ORR): best overall response of complete response (CR) or partial response (PR) to a first line of treatment using RECIST 1.1 criteria as assessed locally |
| Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 |
| Progression-free survival (PFS) | PFS of the first line of treatment using RECIST 1.1 criteria assessed locally defined as the time from first treatment start to disease progression or death for any cause expressed in months | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 |
| Overall survival (OS) | OS defined as the time from first treatment start to death for any cause expressed in months | Retrospective-data collected on patients diagnosed with NEC between 01 January 2014 and 31 December 2016 |
| Aix-en-Provence |
| 13100 |
| France |
| Centre Hospitalier Universitaire | Angers | 49033 | France |
| Site 05 | Bastia | 20200 | France |
| Site 22 | Beauvais | 60021 | France |
| Centre Hospitalier du Morvan | Brest | 29200 | France |
| Site 43 | Caen | 14000 | France |
| Site 48 | Clermont-Ferrand | 63000 | France |
| Site 33 | Créteil | 94010 | France |
| Site 32 | Elbeuf | 76503 | France |
| Site 04 | Gap | 05000 | France |
| Centre Hospitalier Les Oudairies | La Roche-sur-Yon | 85000 | France |
| Centre Hospitalier Universitaire DUPUYTREN | Limoges | 87042 | France |
| Hospital du Cluzeau | Limoges | 87042 | France |
| Site 00 | Limoges | France |
| Centre Hospitalier Lyon Sud | Lyon | 69495 | France |
| Site 25 | Mantes-la-Jolie | 78200 | France |
| Site 06 | Marseille | 13274 | France |
| Site 01 | Meaux | 77108 | France |
| Site 42 | Orléans | 45032 | France |
| Hospital Saint Antoine | Paris | 75012 | France |
| Site 26 | Paris | 75012 | France |
| Site 19 | Périgueux | 24019 | France |
| Site 02 | Reims | 51092 | France |
| Site 18 | Rouen | 76031 | France |
| Site 17 | Rouen | 76233 | France |
| Site 14 | Toulon | 83800 | France |
| Site 11 | Villefranche-sur-Saône | 69655 | France |
| ID | Term |
|---|---|
| D004194 | Disease |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D007150 | Immunohistochemistry |
| ID | Term |
|---|---|
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
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