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

Centre Antoine Lacassagne1 site in 1 country238 target enrollmentMarch 3, 2025

ConditionsNeoplasm Malignant

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Neoplasm Malignant
Sponsor: Centre Antoine Lacassagne
Enrollment: 238
Locations: 1
Primary Endpoint: Sensitivity of liquid biopsy versus solid biopsy (gold standard)
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

March 3, 2025

End Date

June 3, 2027

Last Updated

last year

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Centre Antoine Lacassagne

Responsible Party

Sponsor

Eligibility Criteria

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
•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.

Outcomes

Primary Outcomes

Sensitivity of liquid biopsy versus solid biopsy (gold standard)

Time Frame: 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).