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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01332-45 | Other Identifier | ANSM |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood sample taken for the liquid biopsy | Procedure | 36 mL will be taken for the study. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of liquid biopsy versus solid biopsy (gold standard) | The specificity of liquid biopsy versus solid biopsy as the gold standard in the detection of genomic alterations evaluated in the studied gene panel. | 1 month |
| Failure rate of molecular screening |
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Inclusion Criteria:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Study coordinator | Contact | +33 04 92 03 14 76 | DRCI-Promotion@nice.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Antoine Lacassagne | Recruiting | Nice | 06189 | France |
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The failure rate of molecular screening (defined as the inability to provide the genetic profile from the liquid biopsy due to technical failure). |
| 1 month |
| Clinical factors predictive of the sensitivity of liquid biopsy. | Clinical factors predictive of the sensitivity of liquid biopsy. | 1 month |
| Rate of unexploitable results | 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. | 1 month |
| Time required to obtain each analysis | The time required to obtain each analysis, defined as the time between the prescription of the test and the delivery of the result. | 1 month |
| ID | Term |
|---|---|
| D009369 | Neoplasms |
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