NCT05380414

Brief Summary

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 Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for not_applicable

Timeline
13mo left

Started Jul 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress79%
Jul 2022Sep 2027

First Submitted

Initial submission to the registry

May 10, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

5.2 years

First QC Date

May 10, 2022

Last Update Submit

March 26, 2026

Conditions

Metastatic Pancreatic CancerAdvanced Pancreatic Cancer

Keywords

Molecular screeningGenomic profilesTranscriptomic profiles

Outcome Measures

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.

    At the end of study (5 years)

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Other Outcomes (4)

  • Genomic data from Next generation sequencing with gene mutations

    At the end of study (5 years)

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

    At the end of study (5 years)

  • Enumeration of CTCs

    At the end of study ( 5 years)

  • +1 more other outcomes

Study Arms (1)

Metastatic/advanced PDAC Patients

EXPERIMENTAL

Tumor samples

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

Interventions

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

Molecular screening

Metastatic/advanced PDAC Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Léon Bérard

Lyon, 69373, France

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Study Officials

  • Philippe CASSIER, MD, PhD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Philippe CASSIER, MD, PhD

CONTACT

0426556833philippe.cassier@lyon.unicancer.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 10, 2022

First Posted

May 18, 2022

Study Start

July 1, 2022

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

September 1, 2027

Last Updated

March 31, 2026

Record last verified: 2026-03

Locations

FR(1)