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

February 28, 2023 updated by: Institut Bergonié

Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

580

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Diagnostic test: EGFR gene mutation analysis on liquid biopsy
Blood samples will be collected at inclusion for plasma DNA collection and analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To assess the detection rate of patients with an EGFR actionable alteration when using the combination of two diagnostic procedures which include liquid biopsy analysis (by droplet digital PCR or allele specific PCR) and tissue analysis
Time Frame: within 3 weeks after signature of informed consent
Resuls of each EGFR diagnostic procedure will be categorized as EGFR positive in case of the presence of an EGFR actionnable alteration ; as EGFR negative in case of the absence of an EGFR actionnable alteration ; or nor interpretable. A patient will be considered to have an EGFR actionable alteration if the mutation has been detected on the sequencing of tumor tissue OR if it has been detected on the liquid biopsy procedure
within 3 weeks after signature of informed consent

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only
Time Frame: within 3 weeks after signature of informed consent
A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by the liquid biopsy analysis if an EGFR actionable alteration is identified based on the liquid biopsy analysis
within 3 weeks after signature of informed consent
The detection rate of patients with an EGFR actionable alteration based on tissue analysis only
Time Frame: within 3 weeks after signature of informed consent
A patient will be considered to have an EGFR actionable alteration (EGFR+) detected by tissue analysis if an EGFR actionable alteration is identified based on the sequencing of tumor tissue
within 3 weeks after signature of informed consent
The concordance and discordance rates between the two procedures
Time Frame: within 3 weeks after signature of informed consent
Concordance is defined whenever results of both techniques are identical (i.e. EGFR+ for both techniques or EGFR- for both techniques). Discordance is defined whenever results of both techniques are different.
within 3 weeks after signature of informed consent
The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)
Time Frame: within 3 weeks after signature of informed consent

•

Failure of a procedure (sequencing of tumor tissue or liquid biopsy) is defined whenever the procedure fails to provide an interpretable result (Reasons for failure will be collected, i.e. insufficient DNA quantity, poor DNA quality, insufficient DNA/tissue quantity, poor DNA/tissue quality, analytical failure)
within 3 weeks after signature of informed consent
Delay to obtain sequencing results
Time Frame: within 3 weeks after signature of informed consent
The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure
within 3 weeks after signature of informed consent
Delay for treatment initiation
Time Frame: within 3 months after signature of informed consent
The delay between the date of sample collection and the date of treatment initiation
within 3 months after signature of informed consent

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Bergonié

Collaborators

AstraZeneca

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Anticipated)

January 1, 2025

Study Completion (Anticipated)

January 1, 2026

Study Registration Dates

First Submitted

May 28, 2021

First Submitted That Met QC Criteria

May 28, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

March 1, 2023

Last Update Submitted That Met QC Criteria

February 28, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IB 2021-02
  • 2021-A00685-36 (Other Identifier: ANSM IDRCB Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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