Neoplasm Malignant
Conditions
Keywords
Liquid biopsy
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.
Interventions
PROCEDUREBlood sample taken for the liquid biopsy
36 mL will be taken for the study.
Sponsors
Centre Antoine Lacassagne
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of liquid biopsy versus solid biopsy (gold standard) | 1 month | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of liquid biopsy versus solid biopsy (gold standard) | 1 month | The specificity of liquid biopsy versus solid biopsy as the gold standard in the detection of genomic alterations evaluated in the studied gene panel. |
| Failure rate of molecular screening | 1 month | The failure rate of molecular screening (defined as the inability to provide the genetic profile from the liquid biopsy due to technical failure). |
| Clinical factors predictive of the sensitivity of liquid biopsy. | 1 month | Clinical factors predictive of the sensitivity of liquid biopsy. |
| Rate of unexploitable results | 1 month | The rate of unexploitable results, defined as the rate of results that do not allow for classification for each technique of the results as True Positive, False Positive, False Negative, or True Negative. |
| Time required to obtain each analysis | 1 month | The time required to obtain each analysis, defined as the time between the prescription of the test and the delivery of the result. |
Countries
France
Contacts
CONTACTStudy coordinator
Outcome results
None listed