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

NCT06606366 | Recruiting

• 2 other identifiers: 2020/582024-A01332-45
• Study Type: interventional
• Target: 238
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasm Malignant

Keywords

Liquid biopsy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Specificity of liquid biopsy versus solid biopsy (gold standard)

  1 month

• Failure rate of molecular screening

  1 month

• Clinical factors predictive of the sensitivity of liquid biopsy.

  1 month

• Rate of unexploitable results

  1 month

• Time required to obtain each analysis

  1 month

Study Arms (1)

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

Interventions

Blood sample taken for the liquid biopsy PROCEDURE

36 mL will be taken for the study.

Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Antoine Lacassagne: lead

Study Sites (1)

Centre Antoine Lacassagne

Nice, 06189, France

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Study coordinator

CONTACT

+33 04 92 03 14 76; DRCI-Promotion@nice.unicancer.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2024
• First Posted: September 23, 2024
• Study Start: March 3, 2025
• Primary Completion (Estimated): June 3, 2027
• Study Completion (Estimated): June 3, 2027
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

FR (1)