- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04161417
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
Recruiting
Conditions
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
- Name: Judith Dixon-Hughes
- Phone Number: 01413302718
- Email: judith.dixon@glasgow.ac.uk
Study Locations
-
-
-
Aberdeen, United Kingdom
- Recruiting
- Aberdeen Royal Infirmary
-
Principal Investigator:
- Bassam Alkari
-
Contact:
- Angela Cheyne
- Email: angela.cheyne@nhs.net
-
Belfast, United Kingdom
- Recruiting
- Northern Ireland Cancer Centre
-
Principal Investigator:
- Richard Turkington
-
Contact:
- Marie Shannon
- Email: Marie.Shannon@belfasttrust.hscni.net
-
Birmingham, United Kingdom
- Recruiting
- Queen Elizabeth Hospital
-
Contact:
- Catia Guerreiro
- Email: Catia.Guerreiro@uhb.nhs.uk
-
Principal Investigator:
- Yuk Ting Ma
-
Bournemouth, United Kingdom
- Recruiting
- Royal Bournemouth Hospital
-
Contact:
- Rebecca Milne
- Email: rebecca.milne@rbch.nhs.uk
-
Principal Investigator:
- Tamas Hickish
-
Bristol, United Kingdom
- Recruiting
- Bristol Oncology Centre
-
Contact:
- Francesca Delogu
- Email: Francesca.Delogu@UHBristol.nhs.uk
-
Principal Investigator:
- Stephen Falk
-
Cambridge, United Kingdom
- Recruiting
- Addenbrooke's Hospital
-
Contact:
- Emma Wong
- Email: emma.wong@addenbrookes.nhs.uk
-
Principal Investigator:
- Bristi Basu
-
Cottingham, United Kingdom
- Recruiting
- Castle Hill Hospital
-
Contact:
- Magda Kolodziej
- Email: magdalena.kolodziej@hey.nhs.uk
-
Principal Investigator:
- Anthony Maraveyas
-
Dundee, United Kingdom
- Recruiting
- Ninewells Hospital
-
Principal Investigator:
- Asa Dahle-Smith
-
Contact:
- Helen Cumming
- Email: helencumming@nhs.net
-
Edinburgh, United Kingdom
- Recruiting
- Western General
-
Contact:
- Olga Demyanov
-
Principal Investigator:
- Alan Christie
-
Glasgow, United Kingdom
- Recruiting
- Glasgow Royal Infirmary
-
Contact:
- Susan Thornton
- Email: Susan.Thornton@ggc.scot.nhs.uk
-
Principal Investigator:
- Colin McKay
-
Huddersfield, United Kingdom
- Recruiting
- Huddersfield Royal Infirmary
-
Contact:
- Zuleikha Mulla
- Email: zuleikha.mulla@cht.nhs.uk
-
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:
- Anne Crossley
- Email: anne.crossley1@nhs.net
-
Liverpool, United Kingdom
- Recruiting
- Royal Liverpool Hospital
-
Contact:
- Ruth Stafferton
- Email: Ruth.Stafferton@liverpool.ac.uk
-
Principal Investigator:
- Paula Ganeh
-
London, United Kingdom
- Recruiting
- King's College Hospital
-
Contact:
- Ane Zamalloa
- Email: ane.zamalloa@nhs.net
-
Principal Investigator:
- Andreas Prachalias
-
London, United Kingdom
- Recruiting
- Royal Marsden Hospital
-
Contact:
- Richard Crux
- Email: Richard.Crux@rmh.nhs.uk
-
Principal Investigator:
- Naureen Starling
-
London, United Kingdom
- Recruiting
- University College London Hospital
-
Contact:
- Emen Mohamad
- Email: emen.mohamad@nhs.net
-
Principal Investigator:
- Daniel Hochhauser
-
London, United Kingdom
- Recruiting
- Guy's Hospital
-
Contact:
- Francesca Curran
- Email: francesca.curran@gstt.nhs.uk
-
Principal Investigator:
- Deb Sarker
-
London, United Kingdom
- Recruiting
- Imperial College Healthcare Trust
-
Principal Investigator:
- Harpreet Wasan
-
Contact:
- Sarah Stimpson
- Email: sarah.stimpson@nhs.net
-
London, United Kingdom
- Recruiting
- Royal Free London Hospital
-
Contact:
- Tahmin Ahmed
- Email: tahmin.ahmed1@nhs.net
-
Principal Investigator:
- Giuseppe Fusai
-
London, United Kingdom
- Recruiting
- St Bart's Hospital
-
Principal Investigator:
- Hemant Kocher
-
Contact:
- Sultana Begum
- Email: sultana.begum16@nhs.net
-
London, United Kingdom
- Recruiting
- St George's Hospital
-
Contact:
- Robert Varro
- Email: robert.varro@stgeorges.nhs.uk
-
Principal Investigator:
- Anna-Mary Young
-
Manchester, United Kingdom
- Recruiting
- Manchester Royal Infirmary
-
Contact:
- Alice Panes
- Email: Alice.Panes@mft.nhs.uk
-
Principal Investigator:
- Derek O'Reilly
-
Manchester, United Kingdom
- Recruiting
- The Christie, Manchester
-
Contact:
- Helen Staiger
- Email: Helen.Staiger@christie.nhs.uk
-
Principal Investigator:
- Juan Valle
-
Milton Keynes, United Kingdom
- Recruiting
- Milton Keynes Hospital
-
Contact:
- Chloe Green
- Email: chloe.green@mkuh.nhs.uk
-
Principal Investigator:
- Wasiru Saka
-
Newcastle, United Kingdom
- Recruiting
- Freeman Hospital
-
Contact:
- Jasmin Snowdon
- Email: Jasmin.Snowdon@nuth.nhs.uk
-
Principal Investigator:
- Kofi Oppong
-
Nottingham, United Kingdom
- Recruiting
- Nottingham Hospitals NHS Trust
-
Principal Investigator:
- Arvind Arora
-
Contact:
- Kerri Jenkins
- Email: Kerri.Jenkins@nuh.nhs.uk
-
Oxford, United Kingdom
- Recruiting
- Churchill Hospital
-
Contact:
- Richard Cousins
- Email: trialadministrator08@oncology.ox.ac.uk
-
Principal Investigator:
- Kinnari Patel
-
Poole, United Kingdom
- Recruiting
- Pool Hospital
-
Principal Investigator:
- Lachlan Ayres
-
Contact:
- Rachel Barnsley
- Email: rachel.barnsley@poole.nhs.uk
-
Sheffield, United Kingdom
- Recruiting
- Weston Park
-
Principal Investigator:
- Jonathan Wadsley
-
Contact:
- Cyper Allan
- Email: c.allan@sheffield.ac.uk
-
Southampton, United Kingdom
- Recruiting
- University Hospital Southampton
-
Principal Investigator:
- Andrew Bateman
-
Contact:
- Liane Armstrong
- Email: liane.armstrong@uhs.nhs.uk
-
Swansea, United Kingdom
- Recruiting
- Morriston Hospital
-
Principal Investigator:
- Bilal Al-Sarireh
-
Contact:
- Karen Phillips
- Email: karen.phillips6@wales.nhs.uk
-
Wigan, United Kingdom
- Recruiting
- Royal Albert Edward Infirmary
-
Contact:
- Louise Devereaux
- Email: Louise.Devereaux@wwl.nhs.uk
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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.
Sponsor
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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