Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients

NCT ID: NCT04912687

Last Updated: 2025-08-13

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

RECRUITING

Clinical Phase

NA

Total Enrollment

580 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2027-08-01

Brief Summary

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Multicenter prospective cohort study aiming to evaluate the detection rate of EGFR gene mutation in patients with advanced NSCLC in a real-word clinical setting, based on liquid biopsy and tissue analyses.

Detailed Description

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This a multicenter prospective cohort study. This study will be proposed to newly diagnosed advanced NSCLC patients. For included patients, archived paraffin embedded tumor tissue will be used for sequencing ; and blood sample will be collected for research purpose (plasma DNA collection and sequencing).

Both tissue and liquid biopsy samples will follow usual processes and will be sent to the Molecular Pathology laboratory of the Investigation center.

Conditions

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Non Small Cell Lung Cancer Advanced Solid Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

This is a multicentric prospective cohort in which newly diagnosed advanced NSCLC patients will be included. For all patients, both tumor and liquid biopsy samples will be used for sequencing and detection of EGFR gene mutation
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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All patients

For all patients, blood sample will be collected at inclusion (liquid biopsy) for sequencing.

As per standard management, for all of these patients, EGFR gene mutation will be also analyzed on archived tumor sample.

Group Type EXPERIMENTAL

EGFR gene mutation analysis on liquid biopsy

Intervention Type DIAGNOSTIC_TEST

Blood samples will be collected at inclusion for plasma DNA collection and analysis.

Interventions

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EGFR gene mutation analysis on liquid biopsy

Blood samples will be collected at inclusion for plasma DNA collection and analysis.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

1. Male or female patients aged ≥ 18 years at time of proposal study,
2. Histologically confirmed non-small cell lung carcinoma,
3. No previous treatment for NSCLC,
4. Indication to EGFR status determination following HAS recommendation,
5. Voluntary signed and dated written informed consent prior to any study specific procedure
6. Patients with a social security in compliance with the French Law.

Exclusion Criteria

1. Treatment for advanced NSCLC started before liquid biopsy sampling.
2. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role collaborator

Institut Bergonié

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut de Cancérologie de l'Ouest - Site Paul Papin

Angers, , France

Site Status NOT_YET_RECRUITING

Institut Bergonie

Bordeaux, , France

Site Status RECRUITING

CHRU Lille

Lille, , France

Site Status NOT_YET_RECRUITING

Hospices Civils de Lyon

Lyon, , France

Site Status RECRUITING

CHU Nice-Hopital de Cimiel

Nice, , France

Site Status RECRUITING

Institut Curie

Paris, , France

Site Status NOT_YET_RECRUITING

CHU Poitiers

Poitiers, , France

Site Status NOT_YET_RECRUITING

CHU de Rennes - Hopital Pontchaillou

Rennes, , France

Site Status RECRUITING

CHU Strasbourg

Strasbourg, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Isabelle SOUBEYRAN, MD, PhD

Role: CONTACT

(0)5.56.33.33.33

Simone MATHOULIN-PELISSIER, MD, PhD

Role: CONTACT

(0)5.56.33.33.33

Facility Contacts

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Alain MOREL, Pr

Role: primary

Sophie COUSIN, Dr

Role: primary

Alexis CORTOT, Pr

Role: primary

Sébastien COURAUD, Pr

Role: primary

Paul HOFMAN, Pr

Role: primary

Catherine DANIEL, Dr

Role: primary

Clotilde DELDYCKE, Dr

Role: primary

Hervé LENA, Dr

Role: primary

Michèle BEAU-FALLER, Pr

Role: primary

Other Identifiers

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2021-A00685-36

Identifier Type: OTHER

Identifier Source: secondary_id

IB 2021-02

Identifier Type: -

Identifier Source: org_study_id

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