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Clinical trial

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

ID
Name
ET21-399 GENOPANC
Description
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.
Trial arms
Trial start
2022-07-01
Estimated PCD
2027-09-01
Trial end
2027-09-01
Status
Recruiting
Treatment
Tumor samples (archival FFPE) and blood samples
Molecular screening
Arms:
Metastatic/advanced PDAC Patients
Size
750
Primary endpoint
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)
Eligibility criteria
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NA', 'interventionModel': 'SINGLE_GROUP', 'primaryPurpose': 'SCREENING', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 750, 'type': 'ESTIMATED'}}
Updated at
2023-07-12

1 organization

1 product

1 indication

Organization
Centre Leon Berard
Product
Tumor samples
Indication
Pancreatic Cancer