Recruiting NCT06606366
Study on the Contribution of the Genetic Tumor Profile Obtained by Circulating Tumor DNA Analysis in the Multidisciplinary Molecular Biology Meeting of Eastern PACA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Blood sample taken for the liquid biopsy.
- Who it may be relevant to
- Registry conditions: Neoplasm Malignant. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Blood sample taken for the liquid biopsy
36 mL will be taken for the study.
Primary outcome measures
- Sensitivity of liquid biopsy versus solid biopsy (gold standard) [Time frame: 1 month]
Secondary outcome measures (5)
- Specificity of liquid biopsy versus solid biopsy (gold standard) [Time frame: 1 month]
- Failure rate of molecular screening [Time frame: 1 month]
- Clinical factors predictive of the sensitivity of liquid biopsy. [Time frame: 1 month]
- Rate of unexploitable results [Time frame: 1 month]
- Time required to obtain each analysis [Time frame: 1 month]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- Centre Antoine Lacassagne — Nice
Identifiers
NCT: NCT06606366 · 2020/58 · 2024-A01332-45