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Profiling Program of Advanced/Metastatic Pancreatic Cancer Patients

L

Léon Bérard Center

Status

Enrolling

Conditions

Metastatic Pancreatic Cancer
Advanced Pancreatic Cancer

Treatments

Biological: Tumor samples (archival FFPE) and blood samples

Study type

Interventional

Funder types

Other

Identifiers

NCT05380414
ET21-399 GENOPANC

Details and patient eligibility

About

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.

Enrollment

750 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Screening

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

750 participants in 1 patient group

Metastatic/advanced PDAC Patients
Experimental group
Description:
Tumor samples
Treatment:
Biological: Tumor samples (archival FFPE) and blood samples

Trial contacts and locations

1

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Central trial contact

Philippe CASSIER, MD, PhD

Data sourced from clinicaltrials.gov

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