Evaluation of PD-L1 (Programmed Death-Ligand 1) Tumor Expression in Patients With Large-cell Neuroendocrine Carcinoma (NEC)

NCT ID: NCT03305133

Last Updated: 2020-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-09-26

Study Completion Date

2018-10-30

Brief Summary

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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.

Detailed Description

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Conditions

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Large Cell Lung Cancer Neuroendocrine Carcinoma of Lung (Diagnosis)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Immunohistochemistry

The slides which allowed the large cell neuroendocrine carcinoma diagnosis will be re-read centrally.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged \> or = 18 years
* Diagnosis of Large-cell NEC confirmed by centralised reading
* Tumoral materials available and readable for PD-L1 labeling

Exclusion Criteria

* Other type of Lung cancers
* Tumoral material not available or not readable for centralised reading
* Tumoral material not available or not readable for PD-L1 labeling
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Groupe Francais De Pneumo-Cancerologie

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dominque Arpin, MD

Role: PRINCIPAL_INVESTIGATOR

Service de pneumologie et oncologie thoracique - Hôpital Nord-Ouest - F-69400 Villefranche sur Saône

Locations

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Centre Hospitalier D Argenteuil

Argenteuil, VAL D'oise, France

Site Status

Site 12

Aix-en-Provence, , France

Site Status

Centre Hospitalier Universitaire

Angers, , France

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Site 05

Bastia, , France

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Site 22

Beauvais, , France

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Centre Hospitalier du Morvan

Brest, , France

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Site 43

Caen, , France

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Site 48

Clermont-Ferrand, , France

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Site 33

Créteil, , France

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Site 32

Elbeuf, , France

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Site 04

Gap, , France

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Centre Hospitalier Les Oudairies

La Roche-sur-Yon, , France

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Centre Hospitalier Universitaire DUPUYTREN

Limoges, , France

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Hospital du Cluzeau

Limoges, , France

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Site 00

Limoges, , France

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Centre Hospitalier Lyon Sud

Lyon, , France

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Site 25

Mantes-la-Jolie, , France

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Site 06

Marseille, , France

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Site 01

Meaux, , France

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Site 42

Orléans, , France

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Hospital Saint Antoine

Paris, , France

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Site 26

Paris, , France

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Site 19

Périgueux, , France

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Site 02

Reims, , France

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Site 18

Rouen, , France

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Site 17

Rouen, , France

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Site 14

Toulon, , France

Site Status

Site 11

Villefranche-sur-Saône, , France

Site Status

Countries

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France

Other Identifiers

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GFPC 03-2017

Identifier Type: -

Identifier Source: org_study_id

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