Study on the Contribution of the Genetic Tumor Profile Obtained Through Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA

Not Applicable

Recruiting

• Conditions: Neoplasm Malignant
• Interventions: Procedure: Blood sample taken for the liquid biopsy

• Registration Number: NCT06606366
• Lead Sponsor: Centre Antoine Lacassagne

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-09-18
• Study First Submitted QC: 2024-09-19
• Study First Posted: 2024-09-23
• Study Start: 2025-03-03
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-10
• Last Update Posted: 2025-04-13
• Primary Completion: 2027-06-03
• Study Completion: 2027-06-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 238

Inclusion Criteria

• Age ≥ 18 years.
• 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Blood sample taken for the liquid biopsy	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).

Primary Outcome Measures

Name	Time	Method
Sensitivity of liquid biopsy versus solid biopsy (gold standard)	1 month	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).

Secondary Outcome Measures

Name	Time	Method
Specificity of liquid biopsy versus solid biopsy (gold standard)	1 month	The specificity of liquid biopsy versus solid biopsy as the gold standard in the detection of genomic alterations evaluated in the studied gene panel.
Failure rate of molecular screening	1 month	The failure rate of molecular screening (defined as the inability to provide the genetic profile from the liquid biopsy due to technical failure).
Clinical factors predictive of the sensitivity of liquid biopsy.	1 month	Clinical factors predictive of the sensitivity of liquid biopsy.
Rate of unexploitable results	1 month	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.
Time required to obtain each analysis	1 month	The time required to obtain each analysis, defined as the time between the prescription of the test and the delivery of the result.

Trial Locations

Locations (1)

Centre Antoine Lacassagne; 🇫🇷 Nice, France