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The proposal is to implement a molecular screening program for advanced/metastatic pancreatic cancer patients before the initiation of 1st line treatment in order to allow a better selection of patients for rationale personalized medicine with targeted agents and/or combination involving a chemotherapy backbone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metastatic/advanced PDAC Patients | Experimental | Tumor samples |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tumor samples (archival FFPE and optional de novo biopsy) and blood samples | Biological | Molecular screening |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with at least one actionable alteration defined as an alteration shown to predict for sensitivity to a drug FDA/EMA approved for use in another cancer type, or a relevant alteration for inclusion in a clinical trial. | At the end of study (5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Time from ICF signature to day 1 of next line of therapy | At day 1 | |
| Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated | At the end of study (5 years) |
| Measure | Description | Time Frame |
|---|---|---|
| Genomic data from Next generation sequencing with gene mutations | copy number variations (CNV), Tumor mutational burden (TMB), Microsatellite instability status (MSI), and Homologous recombination status (HR: HRD or HRP) | At the end of study (5 years) |
| Transcriptomic data from RNASeq allowing to look at gene expression, fusion transcripts |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Philippe CASSIER, MD, PhD | Contact | 0426556833 | philippe.cassier@lyon.unicancer.fr |
| Name | Affiliation | Role |
|---|---|---|
| Philippe CASSIER, MD, PhD | Centre Leon Berard | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| Progression-Free Survival (PFS) | Up to 12 months |
| Best overall response (BoR) | Up to 12 months |
| Overall survival (OS) | Up to 12 months |
| Duration of response (DoR) | Up to 12 months |
to classify tumors in previously described molecular classification and to annotate tumors based on specific biological features (Epithelial-to-Mesenchymal status, CD10 signature, HOT score, …) |
| At the end of study (5 years) |
| Enumeration of CTCs | to follow clinical response to the treatment. | At the end of study ( 5 years) |
| Profile of surface antigens of CTCs obtained by flow cytometry | to confirm cell identity and follow the expression of new receptors predictive of treatment resistance (Her2, Met …) | At the end of study (5 years) |
| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |