Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

July 11, 2023 updated by: Centre Leon Berard

A Single-center, Prospective 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

750

Phase

  • Not Applicable

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

Study Locations

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.
Time Frame: At the end of study (5 years)
At the end of study (5 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to 12 months
Up to 12 months
Time from ICF signature to day 1 of next line of therapy
Time Frame: At day 1
At day 1
Number of patients initiating a targeted therapy according to this molecular screening program with type of therapy initiated
Time Frame: At the end of study (5 years)
At the end of study (5 years)
Best overall response (BoR)
Time Frame: Up to 12 months
Up to 12 months
Overall survival (OS)
Time Frame: Up to 12 months
Up to 12 months
Duration of response (DoR)
Time Frame: Up to 12 months
Up to 12 months

Collaborators and Investigators

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

Sponsor

Centre Leon Berard

Investigators

  • Principal Investigator: Philippe CASSIER, MD, PhD, Centre LEON BERARD

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 Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

May 10, 2022

First Submitted That Met QC Criteria

May 16, 2022

First Posted (Actual)

May 18, 2022

Study Record Updates

Last Update Posted (Actual)

July 12, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ET21-399 GENOPANC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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