Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer

Study Overview

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.

N/A

Neoplasms Pancreatic

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

GN17on293

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2019-10-24	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2024-02-07
First Submitted that Met QC Criteria 2019-11-11	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2024-02-08
First Posted (ACTUAL) 2019-11-13	Results First Posted N/A	Last Verified 2024-02

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Screening

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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	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

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

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

Primary Outcome Measures	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	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	Measure Description	Time Frame
Overall Survival	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	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

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
16 Years

Accepts Healthy Volunteers:

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).

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).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Cancer Research UK
NHS Greater Glasgow and Clyde

Investigators

PRINCIPAL_INVESTIGATOR: David Chang, University of Glasgow

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General 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.

Learn

Resources

PatientS

Caregivers

Clinical Trial Record