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

NCT ID: NCT06606366

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

238 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-03

Study Completion Date

2027-06-03

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasm Malignant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

Blood sample taken for the liquid biopsy

Intervention Type PROCEDURE

36 mL will be taken for the study.

Interventions

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Blood sample taken for the liquid biopsy

36 mL will be taken for the study.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Antoine Lacassagne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Antoine Lacassagne

Nice, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Study coordinator

Role: CONTACT

+33 04 92 03 14 76

Facility Contacts

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Study coordinator

Role: primary

Other Identifiers

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2024-A01332-45

Identifier Type: OTHER

Identifier Source: secondary_id

2020/58

Identifier Type: -

Identifier Source: org_study_id

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