Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

NCT ID: NCT04161417

Last Updated: 2024-02-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

2500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-28

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Neoplasms Pancreatic

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Biopsy Material Required for Registration

The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer

Group Type OTHER

Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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).
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cancer Research UK

OTHER

Sponsor Role collaborator

NHS Greater Glasgow and Clyde

OTHER

Sponsor Role collaborator

Judith Dixon-Hughes

OTHER

Sponsor Role lead

Responsible Party

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Judith Dixon-Hughes

Project Manager

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Chang

Role: PRINCIPAL_INVESTIGATOR

University of Glasgow

Juan Valle

Role: PRINCIPAL_INVESTIGATOR

University of Manchester

Locations

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Aberdeen Royal Infirmary

Aberdeen, , United Kingdom

Site Status RECRUITING

Northern Ireland Cancer Centre

Belfast, , United Kingdom

Site Status RECRUITING

Queen Elizabeth Hospital

Birmingham, , United Kingdom

Site Status RECRUITING

Royal Bournemouth Hospital

Bournemouth, , United Kingdom

Site Status RECRUITING

Bristol Oncology Centre

Bristol, , United Kingdom

Site Status RECRUITING

Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status RECRUITING

Castle Hill Hospital

Cottingham, , United Kingdom

Site Status RECRUITING

Ninewells Hospital

Dundee, , United Kingdom

Site Status RECRUITING

Western General

Edinburgh, , United Kingdom

Site Status RECRUITING

Glasgow Royal Infirmary

Glasgow, , United Kingdom

Site Status RECRUITING

Huddersfield Royal Infirmary

Huddersfield, , United Kingdom

Site Status RECRUITING

Raigmore Hospital

Inverness, , United Kingdom

Site Status RECRUITING

St James's Hospital

Leeds, , United Kingdom

Site Status RECRUITING

Royal Liverpool Hospital

Liverpool, , United Kingdom

Site Status RECRUITING

Guy's Hospital

London, , United Kingdom

Site Status RECRUITING

Imperial College Healthcare Trust

London, , United Kingdom

Site Status RECRUITING

King's College Hospital

London, , United Kingdom

Site Status RECRUITING

Royal Free London Hospital

London, , United Kingdom

Site Status RECRUITING

Royal Marsden Hospital

London, , United Kingdom

Site Status RECRUITING

St Bart's Hospital

London, , United Kingdom

Site Status RECRUITING

St George's Hospital

London, , United Kingdom

Site Status RECRUITING

University College London Hospital

London, , United Kingdom

Site Status RECRUITING

Manchester Royal Infirmary

Manchester, , United Kingdom

Site Status RECRUITING

The Christie, Manchester

Manchester, , United Kingdom

Site Status RECRUITING

Milton Keynes Hospital

Milton Keynes, , United Kingdom

Site Status RECRUITING

Freeman Hospital

Newcastle, , United Kingdom

Site Status RECRUITING

Nottingham Hospitals NHS Trust

Nottingham, , United Kingdom

Site Status RECRUITING

Churchill Hospital

Oxford, , United Kingdom

Site Status RECRUITING

Pool Hospital

Poole, , United Kingdom

Site Status RECRUITING

Weston Park

Sheffield, , United Kingdom

Site Status RECRUITING

University Hospital Southampton

Southampton, , United Kingdom

Site Status RECRUITING

Morriston Hospital

Swansea, , United Kingdom

Site Status RECRUITING

Royal Albert Edward Infirmary

Wigan, , United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Judith Dixon-Hughes

Role: CONTACT

01413302718

Facility Contacts

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Angela Cheyne

Role: primary

Marie Shannon

Role: primary

Catia Guerreiro

Role: primary

Rebecca Milne

Role: primary

Francesca Delogu

Role: primary

Emma Wong

Role: primary

Magda Kolodziej

Role: primary

Helen Cumming

Role: primary

Olga Demyanov

Role: primary

Susan Thornton

Role: primary

Zuleikha Mulla

Role: primary

Laura McLennan

Role: primary

Anne Crossley

Role: primary

Ruth Stafferton

Role: primary

Francesca Curran

Role: primary

Sarah Stimpson

Role: primary

Ane Zamalloa

Role: primary

Tahmin Ahmed

Role: primary

Richard Crux

Role: primary

Sultana Begum

Role: primary

Robert Varro

Role: primary

Emen Mohamad

Role: primary

Alice Panes

Role: primary

Helen Staiger

Role: primary

Chloe Green

Role: primary

Jasmin Snowdon

Role: primary

Kerri Jenkins

Role: primary

Richard Cousins

Role: primary

Rachel Barnsley

Role: primary

Cyper Allan

Role: primary

Liane Armstrong

Role: primary

Karen Phillips

Role: primary

Louise Devereaux

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37378896 (View on PubMed)

Other Identifiers

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GN17on293

Identifier Type: -

Identifier Source: org_study_id

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