Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA (TARGET)

This study will evaluate the diagnostic performance of liquid biopsy for identifying molecular abnormalities among patients managed by the Multidisciplinary Molecular Biology Meeting. The gold standard considered in this study is the solid biopsy.

Study Overview

• Status: Recruiting
• Conditions: Neoplasm Malignant
• Intervention / Treatment: Procedure: Blood sample taken for the liquid biopsy

• Study Type: Interventional
• Enrollment (Estimated): 238
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study coordinator; Phone Number: +33 04 92 03 14 76; Email: DRCI-Promotion@nice.unicancer.fr

Study Locations

• France
  • Nice, France, 06189
    • Recruiting
    • Centre Antoine Lacassagne
    • Contact: Study coordinator; Email: DRCI-Promotion@nice.unicancer.fr
    • Contact: Esma SAADA-BOUZID

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Over 18 years old.
• Advanced-stage malignant solid tumor managed in a non-curative context.
• Patient eligible for Multidisciplinary molecular biology meeting with available archived tumor material (frozen or FFPE block, less than 5 years old) or a biopsiable tumor lesion.
• Performance status of 0 or 1.
• Patient able to read, write, and understand the French language.
• Patient has read the information sheet and signed the informed consent.
• Patient has social security coverage.

Exclusion Criteria:

• Previous or concurrent cancer diagnosed or treated within the last 5 years, except for in situ carcinoma of the cervix, basal cell or squamous cell carcinoma of the skin, and adequately treated in situ carcinoma of the bladder.
• Severe or uncontrolled systemic disease.
• Any condition which, in the investigator's judgment (geographical, social, or psychological factors, etc.), makes the patient unable to comply with study follow-up and procedures.

• Patient considered a vulnerable person; vulnerable persons are defined in Articles L1121-5 to L1121-8:

  • Pregnant women, women in labor, and breastfeeding mothers,
  • Persons deprived of liberty by judicial or administrative decision, individuals hospitalized without consent under Articles L. 3212-1 and L. 3213-1 who do not fall under the provisions of Article L. 1121-8,
  • Persons admitted to a healthcare or social institution for reasons other than research,
  • Adults unable to give their consent.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; For this study, the included patients will have a blood sample (36 mL) taken. Molecular analyses will be performed on this blood sample (liquid biopsy) in addition to the molecular analyses routinely conducted on the tumor sample (solid biopsy).	Procedure: Blood sample taken for the liquid biopsy; 36 mL will be taken for the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of liquid biopsy versus solid biopsy (gold standard)	The primary endpoind is the sensitivity of liquid biopsy versus solid biopsy as the gold standard for detecting genomic alterations evaluated in the studied gene panel. The panel will consist of 70 genes common to the PanoraMix panels (125 genes, FFPE) and Avida (104 genes, cpDNA).	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Failure rate of molecular screening	The failure rate of molecular screening (defined as the inability to provide the genetic profile from the liquid biopsy due to technical failure).	1 month
Clinical factors predictive of the sensitivity of liquid biopsy.	Clinical factors predictive of the sensitivity of liquid biopsy.	1 month
Time required to obtain each analysis	The time required to obtain each analysis, defined as the time between the prescription of the test and the delivery of the result.	1 month
Specificity of liquid biopsy versus solid biopsy (gold standard)	The specificity of liquid biopsy versus solid biopsy as the gold standard in the detection of genomic alterations evaluated in the studied gene panel.	1 month
Rate of unexploitable results	The rate of unexploitable results, defined as the rate of results that do not allow for classification for each technique of the results as True Positive, False Positive, False Negative, or True Negative.	1 month

Collaborators and Investigators

• Sponsor: Centre Antoine Lacassagne

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2025
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027

Study Registration Dates

• First Submitted: September 18, 2024
• First Submitted That Met QC Criteria: September 19, 2024
• First Posted (Actual): September 23, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 10, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Liquid biopsy
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 2020/58; 2024-A01332-45 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No