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

Primary Purpose

Non Small Cell Lung Cancer, Advanced Solid Tumor

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
EGFR gene mutation analysis on liquid biopsy
Sponsored by
Institut Bergonié
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Non Small Cell Lung Cancer focused on measuring non-small cell lung cancer, EGFR detection, liquid biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Institut de Cancérologie de l'Ouest - Site Paul Papin
  • Institut BergonieRecruiting
  • CHRU Lille
  • Hospices Civils de LyonRecruiting
  • CHU Nice-Hopital de CimielRecruiting
  • Institut Curie
  • CHU Poitiers
  • CHU de Rennes - Hopital PontchaillouRecruiting
  • CHU StrasbourgRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

All patients

Arm Description

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only
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
The detection rate of patients with an EGFR actionable alteration based on tissue analysis only
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
The concordance and discordance rates between the two procedures
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.
The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)
• 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)
Delay to obtain sequencing results
The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure
Delay for treatment initiation
The delay between the date of sample collection and the date of treatment initiation

Full Information

First Posted
May 28, 2021
Last Updated
February 28, 2023
Sponsor
Institut Bergonié
Collaborators
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT04912687
Brief Title
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced NSCLC Patients
Acronym
CIRCULAR
Official Title
Implementing Circulating Tumor DNA Analysis at Initial Diagnosis to Improve Management of Advanced Non-small Cell Lung Cancer Patients (NSCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
January 1, 2025 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut Bergonié
Collaborators
AstraZeneca

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Cancer, Advanced Solid Tumor
Keywords
non-small cell lung cancer, EGFR detection, liquid biopsy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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
Masking
None (Open Label)
Allocation
N/A
Enrollment
580 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
All patients
Arm Type
Experimental
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
EGFR gene mutation analysis on liquid biopsy
Intervention Description
Blood samples will be collected at inclusion for plasma DNA collection and analysis.
Primary Outcome Measure Information:
Title
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
Description
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
Time Frame
within 3 weeks after signature of informed consent
Secondary Outcome Measure Information:
Title
The detection rate of patients with an EGFR actionable alteration based on the use of liquid biopsy analysis only
Description
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
Time Frame
within 3 weeks after signature of informed consent
Title
The detection rate of patients with an EGFR actionable alteration based on tissue analysis only
Description
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
Time Frame
within 3 weeks after signature of informed consent
Title
The concordance and discordance rates between the two procedures
Description
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.
Time Frame
within 3 weeks after signature of informed consent
Title
The failure rate for each procedure and reasons of failure (insufficient DNA quantity, poor DNA quality, insufficient tissue quantity, poor tissue quality, analytical failure)
Description
• 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)
Time Frame
within 3 weeks after signature of informed consent
Title
Delay to obtain sequencing results
Description
The delay between the date of the signature of the informed consent and the date of availability of the results for each procedure
Time Frame
within 3 weeks after signature of informed consent
Title
Delay for treatment initiation
Description
The delay between the date of sample collection and the date of treatment initiation
Time Frame
within 3 months after signature of informed consent

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female patients aged ≥ 18 years at time of proposal study, Histologically confirmed non-small cell lung carcinoma, No previous treatment for NSCLC, Indication to EGFR status determination following HAS recommendation, Voluntary signed and dated written informed consent prior to any study specific procedure Patients with a social security in compliance with the French Law. Exclusion Criteria: Treatment for advanced NSCLC started before liquid biopsy sampling. Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isabelle SOUBEYRAN, MD, PhD
Phone
(0)5.56.33.33.33
Email
i.soubeyran@bordeaux.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Simone MATHOULIN-PELISSIER, MD, PhD
Phone
(0)5.56.33.33.33
Email
s.mathoulin@bordeaux.unicancer.fr
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest - Site Paul Papin
City
Angers
ZIP/Postal Code
49000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alain MOREL, Pr
Email
alain.morel@ico.unicancer.fr
Facility Name
Institut Bergonie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sophie COUSIN, Dr
Email
s.cousin@bordeaux.unicancer.fr
Facility Name
CHRU Lille
City
Lille
ZIP/Postal Code
59037
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexis CORTOT, Pr
Email
alexis.cortot@chru-lille.fr
Facility Name
Hospices Civils de Lyon
City
Lyon
ZIP/Postal Code
69002
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sébastien COURAUD, Pr
Email
sebastien.couraud@chu-lyon.fr
Facility Name
CHU Nice-Hopital de Cimiel
City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul HOFMAN, Pr
Email
hofman.p@chu-nice.fr
Facility Name
Institut Curie
City
Paris
ZIP/Postal Code
75248
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine DANIEL, Dr
Email
catherine.daniel@curie.fr
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Clotilde DELDYCKE, Dr
Email
clotilde.deldycke@chu-poitiers.fr
Facility Name
CHU de Rennes - Hopital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hervé LENA, Dr
Email
herve.lena@chu-rennes.fr
Facility Name
CHU Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michèle BEAU-FALLER, Pr
Email
michele.beau@chru-strasbourg.fr

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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