Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

February 7, 2024 updated by: Judith Dixon-Hughes

Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer

The Precision-Panc Master Protocol is a "portal" protocol for patients with known or suspected pancreatic cancer to be accrued through multiple centres in the UK, with the option of being subsequently enrolled into PRIMUS (Pancreatic canceR Individualised Multi-arm Umbrella Studies) examining different treatment regimens and/or biomarker development. Eligible patients will undergo tumour biopsy and blood collection prospectively for molecular profiling at a central laboratory and the results may be used to inform enrolment to PRIMUS studies.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

2500

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

      • Aberdeen, United Kingdom
        • Recruiting
        • Aberdeen Royal Infirmary
        • Principal Investigator:
          • Bassam Alkari
        • Contact:
      • Belfast, United Kingdom
      • Birmingham, United Kingdom
        • Recruiting
        • Queen Elizabeth Hospital
        • Contact:
        • Principal Investigator:
          • Yuk Ting Ma
      • Bournemouth, United Kingdom
        • Recruiting
        • Royal Bournemouth Hospital
        • Contact:
        • Principal Investigator:
          • Tamas Hickish
      • Bristol, United Kingdom
      • Cambridge, United Kingdom
      • Cottingham, United Kingdom
      • Dundee, United Kingdom
        • Recruiting
        • Ninewells Hospital
        • Principal Investigator:
          • Asa Dahle-Smith
        • Contact:
      • Edinburgh, United Kingdom
        • Recruiting
        • Western General
        • Contact:
          • Olga Demyanov
        • Principal Investigator:
          • Alan Christie
      • Glasgow, United Kingdom
      • Huddersfield, United Kingdom
        • Recruiting
        • Huddersfield Royal Infirmary
        • Contact:
        • Principal Investigator:
          • Emma Rathbone
      • Inverness, United Kingdom
        • Recruiting
        • Raigmore Hospital
        • Principal Investigator:
          • Stephen McNally
        • Contact:
          • Laura McLennan
      • Leeds, United Kingdom
        • Recruiting
        • St James's Hospital
        • Principal Investigator:
          • Andrew Smith
        • Contact:
      • Liverpool, United Kingdom
      • London, United Kingdom
        • Recruiting
        • King's College Hospital
        • Contact:
        • Principal Investigator:
          • Andreas Prachalias
      • London, United Kingdom
        • Recruiting
        • Royal Marsden Hospital
        • Contact:
        • Principal Investigator:
          • Naureen Starling
      • London, United Kingdom
        • Recruiting
        • University College London Hospital
        • Contact:
        • Principal Investigator:
          • Daniel Hochhauser
      • London, United Kingdom
      • London, United Kingdom
        • Recruiting
        • Imperial College Healthcare Trust
        • Principal Investigator:
          • Harpreet Wasan
        • Contact:
      • London, United Kingdom
        • Recruiting
        • Royal Free London Hospital
        • Contact:
        • Principal Investigator:
          • Giuseppe Fusai
      • London, United Kingdom
        • Recruiting
        • St Bart's Hospital
        • Principal Investigator:
          • Hemant Kocher
        • Contact:
      • London, United Kingdom
      • Manchester, United Kingdom
        • Recruiting
        • Manchester Royal Infirmary
        • Contact:
        • Principal Investigator:
          • Derek O'Reilly
      • Manchester, United Kingdom
      • Milton Keynes, United Kingdom
        • Recruiting
        • Milton Keynes Hospital
        • Contact:
        • Principal Investigator:
          • Wasiru Saka
      • Newcastle, United Kingdom
      • Nottingham, United Kingdom
        • Recruiting
        • Nottingham Hospitals NHS Trust
        • Principal Investigator:
          • Arvind Arora
        • Contact:
      • Oxford, United Kingdom
      • Poole, United Kingdom
      • Sheffield, United Kingdom
        • Recruiting
        • Weston Park
        • Principal Investigator:
          • Jonathan Wadsley
        • Contact:
      • Southampton, United Kingdom
        • Recruiting
        • University Hospital Southampton
        • Principal Investigator:
          • Andrew Bateman
        • Contact:
      • Swansea, United Kingdom
      • Wigan, United Kingdom
        • Recruiting
        • Royal Albert Edward Infirmary
        • Contact:
        • Principal Investigator:
          • Richard Keld

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

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients (age >16 years).
  • Either:

    • Presence of a hypodense pancreatic mass highly suspicious of primary pancreatic cancer with or without distant metastasis as assessed by a Pancreatic Multi-Disciplinary Team (MDT).

Or

o Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants.

  • Patient is willing and able to undergo additional tumour biopsy (from the primary or a metastatic site) aimed at obtaining sufficient tissue for molecular profiling if this is required.
  • Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation.
  • Patient is deemed potentially eligible for a currently open PRIMUS study
  • Patient has signed informed consent for screening research tumour biopsy (Consent 1).
  • Patient has signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2).

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
Other: Biopsy Material Required for Registration
The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer
Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling. This will enable patient enrolment into a currently available PRIMUS study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting
Time Frame: At end of study (5 years)
The number of patients screened and registered to the master protocol will be recorded. The number of patients who we are able to molecular assess will be recorded and all patients will be followed up in the master protocol until death.
At end of study (5 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall Survival
Time Frame: From date of registration until date of death from any cause, assessed up to 5 years
To assess the overall survival (OS) in patients enrolled in Precision-Panc and relate this to molecular profile information.
From date of registration until date of death from any cause, assessed up to 5 years
Number of participants with biopsy related adverse events as assesed by CTCAE v4.03
Time Frame: At time of biopsy, usually within one week of screening
To assess the safety of obtaining tumour biopsies suitable for molecular profiling within a standard patient treatment pathway.
At time of biopsy, usually within one week of screening

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Free Survival
Time Frame: At time of progression (this is estimated at around 6-9 months for this group of patients)
To assess the progression-free survival (PFS) in patients enrolled in Precision-Panc and relate this to molecular profile information
At time of progression (this is estimated at around 6-9 months for this group of patients)

Collaborators and Investigators

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

Investigators

  • Principal Investigator: David Chang, University of Glasgow
  • Principal Investigator: Juan Valle, University of Manchester

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)

November 28, 2017

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 24, 2019

First Submitted That Met QC Criteria

November 11, 2019

First Posted (Actual)

November 13, 2019

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 7, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • GN17on293

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

When the clinical study report at end of study is complete all data will be available to other researchers. Researchers should contact study Trial Management Group for access. All genomic data will be made available through ICGC ARGO.

IPD Sharing Time Frame

On study completion

IPD Sharing Access Criteria

Request to TMG

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ICF
  • CSR

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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