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)

Centre Antoine Lacassagne

Status: Enrolling

Conditions: Neoplasm Malignant

Treatments: Procedure: Blood sample taken for the liquid biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06606366

2020/58

2024-A01332-45 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 238 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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238 participants in 1 patient group

Experimental

Experimental group

Description:

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).

Treatment:

Procedure: Blood sample taken for the liquid biopsy