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Trial Title:
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
Condition:
Neoplasm Malignant
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Liquid biopsy
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Blood sample taken for the liquid biopsy
Description:
36 mL will be taken for the study.
Arm group label:
Experimental
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.
Criteria for eligibility:
Criteria:
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Centre Antoine Lacassagne
Address:
City:
Nice
Zip:
06189
Country:
France
Contact:
Last name:
Study coordinator
Email:
DRCI-Promotion@nice.unicancer.fr
Investigator:
Last name:
Esma SAADA-BOUZID
Email:
Principal Investigator
Start date:
February 2025
Completion date:
May 2027
Lead sponsor:
Agency:
Centre Antoine Lacassagne
Agency class:
Other
Source:
Centre Antoine Lacassagne
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06606366
