Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT05380414
NCT05380414RecruitingNot Applicable

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

Centre Leon Berard1 site in 1 country750 target enrollmentStarted: July 1, 2022Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
750
Locations
1
Primary Endpoint
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.
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Screening
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Metastatic/advanced PDAC Patients

Experimental

Tumor samples

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

Outcomes

Primary Outcomes

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

  • Progression-Free Survival (PFS)(Up to 12 months)
  • Time from ICF signature to day 1 of next line of therapy(At day 1)
  • Overall survival (OS)(Up to 12 months)
  • Duration of response (DoR)(Up to 12 months)
  • Best overall response (BoR)(Up to 12 months)
  • 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))

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Recruiting
Not Applicable
Pancreatic Cancer and Synchronous Liver Metastases Resection Following Neoadjuvant FOLFIRINOXPancreas CancerPancreas AdenocarcinomaPancreas Metastases
NCT06349278Laval University15
Recruiting
Not Applicable
A Pancreatic Cancer Screening Study in Hereditary High Risk IndividualsPancreatic Neoplasms
NCT03250078Nuvance Health200
Recruiting
Not Applicable
Pancreatic Cancer Screening for At-risk IndividualsPancreatic Cancer, Adult
NCT05006131Beth Israel Deaconess Medical Center1,395
Recruiting
Not Applicable
Project for detection of pancreatic cancer at an early stage with curative surgery in Osaka cityPancreatic cancer at an early stage
JPRN-UMIN000026915Tazuke Kofukai Medical Research Institute, Kitano Hospital400
Recruiting
Not Applicable
Pancreatic Cancer Screening Through the Detection of Elastase-1 Combined With Other ExaminationsPancreatic Ductal AdenocarcinomaPancreatic Elastase 1PancreatitisPancreatic Neuroendocrine TumorPancreatic DiseasesPancreatic Neoplasms
NCT06041009Qilu Hospital of Shandong University2,100