Profiling Program Of Advanced/Metastatic Pancreatic Cancer Patients

Study Overview

Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

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.

N/A

Metastatic Pancreatic Cancer
Advanced Pancreatic Cancer

BIOLOGICAL: Tumor samples (archival FFPE) and blood samples

ET21-399 GENOPANC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2022-05-10	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2023-07-11
First Submitted that Met QC Criteria 2022-05-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2023-07-12
First Posted (ACTUAL) 2022-05-18	Results First Posted N/A	Last Verified 2023-07

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Metastatic/advanced PDAC Patients Tumor samples	BIOLOGICAL: Tumor samples (archival FFPE) and blood samples Molecular screening

Participant Group/Arm

Intervention/Treatment

EXPERIMENTAL: Metastatic/advanced PDAC Patients

Tumor samples

BIOLOGICAL: Tumor samples (archival FFPE) and blood samples

Molecular screening

Primary Outcome Measures	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	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

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Philippe CASSIER, MD, PhD

Phone Number: 0426556833

Email: philippe.cassier@lyon.unicancer.fr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Philippe CASSIER, MD, PhD, Centre Leon Berard

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

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Resources

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Caregivers

Clinical Trial Record