Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

Study Overview
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Brief Summary
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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.

Official Title
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A Single-center, Prospective Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

Conditions
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Metastatic Pancreatic Cancer, Advanced Pancreatic Cancer

Intervention / Treatment
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* Biological: Tumor samples (archival FFPE) and blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female patient > 18 years metastatic or advanced PDAC Patient pretreated with no more than one prior systemic chemotherapy for metastatic/advanced disease (radiotherapy is not counted as a line of therapy). Availability of an archival representative FFPE tumor sample from primary tumor (surgery or diagnostic biopsy) and/or from metastatic lesion if metastatic disease at initial diagnosis with associated pathology report from an archival tumor block. Life expectancy > 3 months PS score 0 or 1. Exclusion Criteria: Curative therapy available Any condition contraindicated with blood sampling procedures required by the protocol. Known additional malignancy that is progressing or requires active treatment. Exceptions include adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer. Any psychological, familial, geographic or social situation, according to the judgment of investigator, potentially preventing the provision of informed consent or compliance to study procedure.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Metastatic/advanced PDAC Patients<br>Tumor samples | Biological: Tumor samples (archival FFPE) and blood samples<br>* Molecular screening<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Molecular screening, Genomic profiles, Transcriptomic profiles