Skip to main content
OpenTrials
Recruiting

NCT Number: NCT05380414

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Metastatic Pancreatic Cancer Advanced Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Léon Bérard

Lyon, 69373, France

Location status: Recruiting

Location contact

Philippe CASSIER, MD, PhD

CONTACT

[email protected]

0426556835

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tumor samples (archival FFPE and optional de novo biopsy) and blood samples

Biological

Molecular screening

Primary outcomes

  1. 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)

Secondary outcomes

  1. Time from ICF signature to day 1 of next line of therapy

    Time frame: At day 1

  2. 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)

  3. Progression-Free Survival (PFS)

    Time frame: Up to 12 months

  4. Best overall response (BoR)

    Time frame: Up to 12 months

  5. Overall survival (OS)

    Time frame: Up to 12 months

  6. Duration of response (DoR)

    Time frame: Up to 12 months

Other outcomes

  1. Genomic data from Next generation sequencing with gene mutations

    Time frame: At the end of study (5 years)

    copy number variations (CNV), Tumor mutational burden (TMB), Microsatellite instability status (MSI), and Homologous recombination status (HR: HRD or HRP)

  2. Transcriptomic data from RNASeq allowing to look at gene expression, fusion transcripts

    Time frame: At the end of study (5 years)

    to classify tumors in previously described molecular classification and to annotate tumors based on specific biological features (Epithelial-to-Mesenchymal status, CD10 signature, HOT score, …)

  3. Enumeration of CTCs

    Time frame: At the end of study ( 5 years)

    to follow clinical response to the treatment.

  4. Profile of surface antigens of CTCs obtained by flow cytometry

    Time frame: At the end of study (5 years)

    to confirm cell identity and follow the expression of new receptors predictive of treatment resistance (Her2, Met …)

Study contacts

Contact information is provided by the study sponsor or research team.

Philippe CASSIER, MD, PhD

CONTACT

[email protected]

0426556833

Sponsors and collaborators

Lead sponsor

Centre Leon Berard

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
May 18, 2022
Registry last updated
Mar 31, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.