Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer
1 other identifier
interventional
2,500
1 country
33
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
33 active sites
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 Start
First participant enrolled
November 28, 2017
CompletedFirst Submitted
Initial submission to the registry
October 24, 2019
CompletedFirst Posted
Study publicly available on registry
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedFebruary 8, 2024
February 1, 2024
8.1 years
October 24, 2019
February 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting
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 Outcomes (2)
Overall Survival
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
At time of biopsy, usually within one week of screening
Other Outcomes (1)
Progression Free Survival
At time of progression (this is estimated at around 6-9 months for this group of patients)
Study Arms (1)
Biopsy Material Required for Registration
OTHERThe Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer
Interventions
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
Eligibility Criteria
You may qualify if:
- 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).
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Judith Dixon-Hugheslead
- Cancer Research UKcollaborator
- NHS Greater Glasgow and Clydecollaborator
Study Sites (33)
Aberdeen Royal Infirmary
Aberdeen, United Kingdom
Northern Ireland Cancer Centre
Belfast, United Kingdom
Queen Elizabeth Hospital
Birmingham, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Bristol Oncology Centre
Bristol, United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom
Castle Hill Hospital
Cottingham, United Kingdom
Ninewells Hospital
Dundee, United Kingdom
Western General
Edinburgh, United Kingdom
Glasgow Royal Infirmary
Glasgow, United Kingdom
Huddersfield Royal Infirmary
Huddersfield, United Kingdom
Raigmore Hospital
Inverness, United Kingdom
St James's Hospital
Leeds, United Kingdom
Royal Liverpool Hospital
Liverpool, United Kingdom
Guy's Hospital
London, United Kingdom
Imperial College Healthcare Trust
London, United Kingdom
King's College Hospital
London, United Kingdom
Royal Free London Hospital
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
St Bart's Hospital
London, United Kingdom
St George's Hospital
London, United Kingdom
University College London Hospital
London, United Kingdom
Manchester Royal Infirmary
Manchester, United Kingdom
The Christie, Manchester
Manchester, United Kingdom
Milton Keynes Hospital
Milton Keynes, United Kingdom
Freeman Hospital
Newcastle, United Kingdom
Nottingham Hospitals NHS Trust
Nottingham, United Kingdom
Churchill Hospital
Oxford, United Kingdom
Pool Hospital
Poole, United Kingdom
Weston Park
Sheffield, United Kingdom
University Hospital Southampton
Southampton, United Kingdom
Morriston Hospital
Swansea, United Kingdom
Royal Albert Edward Infirmary
Wigan, United Kingdom
Related Publications (1)
Saha A, Wadsley J, Sirohi B, Goody R, Anthony A, Perumal K, Ulahanan D, Collinson F. Can Concurrent Chemoradiotherapy Add Meaningful Benefit in Addition to Induction Chemotherapy in the Management of Borderline Resectable and Locally Advanced Pancreatic Cancer?: A Systematic Review. Pancreas. 2023 Jan 1;52(1):e7-e20. doi: 10.1097/MPA.0000000000002215.
PMID: 37378896DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
David Chang
University of Glasgow
- PRINCIPAL INVESTIGATOR
Juan Valle
University of Manchester
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Project Manager
Study Record Dates
First Submitted
October 24, 2019
First Posted
November 13, 2019
Study Start
November 28, 2017
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
February 8, 2024
Record last verified: 2024-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF, CSR
- Time Frame
- On study completion
- Access Criteria
- Request to TMG
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.