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

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United Kingdom
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Biopsy Material Required for Registration
The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer
Other: Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Judith Dixon-Hughes

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Cancer Research UK
NHS Greater Glasgow and Clyde

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 28, 2017

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 24, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 11, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 13, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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