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Recruiting NCT07096258

EMPATHY NSCLC: European Registry for Plasma-Based Molecular Profiling in Advanced NSCLC Patients

Observational NSCLC (Advanced Non-small Cell Lung Cancer)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: NSCLC (Advanced Non-small Cell Lung Cancer). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France, Italy, Spain, Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A Patient Registry Collecting the Clinical and Molecular Profiling Data of Patients With Locally Advanced and/or Metastatic, Unresectable, Stages IIIB/C or IV Non-small Cell Lung Cancer (NSCLC), Who Have Not Previously Been Treated for This Advanced Disease and Are Therefore Considered as Patients Receiving First-line Therapy.

Overview

The goal of this registry is to capture real-world data from plasma- and tissue-based molecular profiling, treatments, outcomes and patient-reported outcomes from patients with advanced or metastatic non-small cell lung cancer (NSCLC). The main objective of the study is to better understand the real-world clinical practice of the use and utility of molecular tumour profiling, the choice of treatment, and the outcome after such molecular profiling and treatment.

Primary outcome measures

  • Actionable biomarkers [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • Locally advanced or metastatic, unresectable NSCLC, stages IIIB/C or IV, who have not previously been treated for this advanced disease.
  • Intention-to-initiate first-line tumour therapy for this advanced disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • At least 18 years of age on the day of signing informed consent, and capable of signing informed consent.

Exclusion criteria

  • Any known non-cutaneous malignancy (except for this NSCLC and early-stage non-invasive cervical cancer) that has occurred within 5 years prior to enrolment.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • Université de Lorraine — Nancy
Italy · 1 center
  • University of Naples "Federico II" — Naples
Spain · 1 center
  • General Universitario Gregorio Marañon — Madrid
Switzerland · 1 center
  • Hôpitaux Universitaires Genève — Geneva

Identifiers

NCT: NCT07096258 · EMPATHY NSCLC

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗