Neoplasms PancreaticNCT04161417
Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer
A study testing Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling in people with Neoplasms Pancreatic, run by Judith Dixon-Hughes at 33 sites in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Neoplasms Pancreatic
- What is being tested?
- Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,500 participants
- Where
- 33 sitesUnited Kingdom
- Study dates
- 28 Nov 2017to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
None listed.
Trial locations and contacts
33 sites in 1 country.
33 sites in 1 country
United Kingdom33 sites, 33 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen
Angela Cheyne, angela.cheyne@nhs.net
Bassam Alkari
- Recruiting
Northern Ireland Cancer Centre
Belfast
Marie Shannon, Marie.Shannon@belfasttrust.hscni.net
Richard Turkington
- Recruiting
Queen Elizabeth Hospital
Birmingham
Catia Guerreiro, Catia.Guerreiro@uhb.nhs.uk
Yuk Ting Ma
- Recruiting
Royal Bournemouth Hospital
Bournemouth
Rebecca Milne, rebecca.milne@rbch.nhs.uk
Tamas Hickish
- Recruiting
Bristol Oncology Centre
Bristol
Francesca Delogu, Francesca.Delogu@UHBristol.nhs.uk
Stephen Falk
- Recruiting
Addenbrooke's Hospital
Cambridge
Emma Wong, emma.wong@addenbrookes.nhs.uk
Bristi Basu
- Recruiting
Castle Hill Hospital
Cottingham
Magda Kolodziej, magdalena.kolodziej@hey.nhs.uk
Anthony Maraveyas
- Recruiting
Ninewells Hospital
Dundee
Helen Cumming, helencumming@nhs.net
Asa Dahle-Smith
- Recruiting
Western General
Edinburgh
Olga Demyanov
Alan Christie
- Recruiting
Glasgow Royal Infirmary
Glasgow
Susan Thornton, Susan.Thornton@ggc.scot.nhs.uk
Colin McKay
- Recruiting
Huddersfield Royal Infirmary
Huddersfield
Zuleikha Mulla, zuleikha.mulla@cht.nhs.uk
Emma Rathbone
- Recruiting
Raigmore Hospital
Inverness
Laura McLennan
Stephen McNally
- Recruiting
St James's Hospital
Leeds
Anne Crossley, anne.crossley1@nhs.net
Andrew Smith
- Recruiting
Royal Liverpool Hospital
Liverpool
Ruth Stafferton, Ruth.Stafferton@liverpool.ac.uk
Paula Ganeh
- Recruiting
Guy's Hospital
London
Francesca Curran, francesca.curran@gstt.nhs.uk
Deb Sarker
- Recruiting
Imperial College Healthcare Trust
London
Sarah Stimpson, sarah.stimpson@nhs.net
Harpreet Wasan
- Recruiting
King's College Hospital
London
Ane Zamalloa, ane.zamalloa@nhs.net
Andreas Prachalias
- Recruiting
Royal Free London Hospital
London
Tahmin Ahmed, tahmin.ahmed1@nhs.net
Giuseppe Fusai
- Recruiting
Royal Marsden Hospital
London
Richard Crux, Richard.Crux@rmh.nhs.uk
Naureen Starling
- Recruiting
St Bart's Hospital
London
Sultana Begum, sultana.begum16@nhs.net
Hemant Kocher
- Recruiting
St George's Hospital
London
Robert Varro, robert.varro@stgeorges.nhs.uk
Anna-Mary Young
- Recruiting
University College London Hospital
London
Emen Mohamad, emen.mohamad@nhs.net
Daniel Hochhauser
- Recruiting
Manchester Royal Infirmary
Manchester
Alice Panes, Alice.Panes@mft.nhs.uk
Derek O'Reilly
- Recruiting
The Christie, Manchester
Manchester
Helen Staiger, Helen.Staiger@christie.nhs.uk
Juan Valle
- Recruiting
Milton Keynes Hospital
Milton Keynes
Chloe Green, Chloe.Green@mkuh.nhs.uk
Wasiru Saka
- Recruiting
Freeman Hospital
Newcastle
Jasmin Snowdon, Jasmin.Snowdon@nuth.nhs.uk
Kofi Oppong
- Recruiting
Nottingham Hospitals NHS Trust
Nottingham
Kerri Jenkins, Kerri.Jenkins@nuh.nhs.uk
Arvind Arora
- Recruiting
Churchill Hospital
Oxford
Richard Cousins, trialadministrator08@oncology.ox.ac.uk
Kinnari Patel
- Recruiting
Pool Hospital
Poole
Rachel Barnsley, Rachel.Barnsley@poole.nhs.uk
Lachlan Ayres
- Recruiting
Weston Park
Sheffield
Cyper Allan, c.allan@sheffield.ac.uk
Jonathan Wadsley
- Recruiting
University Hospital Southampton
Southampton
Liane Armstrong, liane.armstrong@uhs.nhs.uk
Andrew Bateman
- Recruiting
Morriston Hospital
Swansea
Karen Phillips, Karen.Phillips6@wales.nhs.uk
Bilal Al-Sarireh
- Recruiting
Royal Albert Edward Infirmary
Wigan
Louise Devereaux, Louise.Devereaux@wwl.nhs.uk
Richard Keld
About this study
Official title: 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.
- Conditions
- Neoplasms Pancreatic
- Being tested
- Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profilingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Biopsy Material Required for Registration | Other | The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer Receives: Other: Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At end of study (5 years)
Secondary outcomes (2)
Overall Survival
To assess the overall survival (OS) in patients enrolled in Precision-Panc and relate this to molecular profile information.
Measured: 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
To assess the safety of obtaining tumour biopsies suitable for molecular profiling within a standard patient treatment pathway.
Measured: At time of biopsy, usually within one week of screening
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2019
- Study start28 Nov 2017
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasms PancreaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study is seen as interventional as patients may have more tissue taken at diagnositic biopsy than if they were not part of the trial or may have an extra biopsy if there is not enough material available from their diagnostic biopsy.
- Masking
- None (open label)
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Judith Dixon-Hughes
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK, NHS Greater Glasgow and Clyde
- Responsible party
- Sponsor-investigator, Judith Dixon-Hughes, University of Glasgow
- Investigators
- David Chang, Principal investigator, University of GlasgowJuan Valle, Principal investigator, University of Manchester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04161417
- Sponsor's protocol ID
- GN17on293
- Status last verified
- Feb 2024
- First submitted
- 24 Oct 2019
- Last updated
- 8 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 37378896
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer
- ClinicalTrials.gov ID
- NCT04161417
- Acronym / sponsor ID
- GN17on293
- Conditions
- Neoplasms Pancreatic
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Judith Dixon-HughesUniversity, hospital or other
- Collaborators
- Cancer Research UK, NHS Greater Glasgow and Clyde
- Study start
- 28 Nov 2017 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The study is seen as interventional as patients may have more tissue taken at diagnositic biopsy than if they were not part of the trial or may have an extra biopsy if there is not enough material available from their diagnostic biopsy.
| Arm | Type | Receives |
|---|---|---|
| Biopsy Material Required for Registration | Other | Other: Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profilingThe Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Adult patients (age >16 years).
- Either:
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profilingPatients 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 | Other | Biopsy Material Required for Registration |
Primary outcome
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.
2 secondary outcomes
Overall Survival
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
- Derived from this study: PubMed 37378896Saha 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Chang principal investigator
University of Glasgow
Juan Valle principal investigator
University of Manchester
33 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling in people with Neoplasms Pancreatic, run by Judith Dixon-Hughes at 33 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Judith Dixon-Hughes (01413302718, judith.dixon@glasgow.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04161417, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.