Condition category
Cancer
Date applied
22/01/2018
Date assigned
29/01/2018
Last edited
26/01/2018
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
At present pancreatic cancer is the 3rd leading cause of cancer death in the western world with only 3% of patients surviving for 5 years or more. Therefore there is an urgent need to both optimise the use of current therapies by identifying responsive (or non-responsive) subgroups and to develop novel therapeutic approaches. The Precision Panc Master Protocol allows for the taking of either extra tissue from a patient's diagnostic biopsy or an additional specific trial biopsy as well as a blood sample. These samples are subjected to molecular profiling and allow for the patient to then be enrolled into a PRIMUS study.

Who can participate?
Adults aged patients aged 16 and older who have a pancreatic mass and are willing to undergo a tumour biopsy.

What does the study involve?
Patients with either suspected or confirmed pancreatic cancer are approached to take part in the study and given the Precision Panc Screening PIS. Participants are given time to consider trial participation and if they are willing to take part in the study they are screened onto the study. If the patient has suspected pancreatic cancer and are having a standard of care diagnostic biopsy, extra cores are taken at that time for the Precision Panc study. If pancreatic ductal adenocarcinoma is confirmed the patient are then given the registration PIS/consent which allows for molecular profiling to take place on the extra tissue taken for research. If the patient already has a diagnosis of pancreatic ductal adenocarcinoma they are asked to undergo and additional research biopsy for the study. All participants are also asked to provide a blood sample for research. The tissue (either the extra diagnostic tissue or the research biopsy) and blood sample are sent to Glasgow for molecular profiling and if enough tissue is available for profiling they may be eligible for an open PRIMUS study.

What are the possible benefits and risks of participating?
It cannot be guaranteed that taking part in this study will benefit participants directly. This is because we cannot be sure that we will identify changes in participant’s tumour make up that will indicate that a specific treatment or clinical trial will work better than any other until the study is undertaken. However, participating in the first stage of Precision-Panc study, will enable the collection of tumour samples that can be studied in detail in the second stage of this study (if cancer diagnosis is made). This information from the tumour sample may help to determine which treatment or clinical trial is best suited to your specific cancer. Participants are invited to allow the study to take a further sample of tissue from participants pancreatic lesion or disease elsewhere such as liver or lung (if applicable), during your routine diagnostic procedure. Before a biopsy is carried out, the risks are discussed with participants directly by the clinical team who do the biopsy, and they obtain your consent for it (Screening Consent). They answer any questions that you may have about the biopsy. If you have been diagnosed with pancreatic cancer already, we will ask you to consent to undergo a new biopsy procedure to obtain samples for research use only. The biopsies can be obtained through interventional radiology procedure or endoscopic ultrasound. This has a few small risks due to discomfort with needles. Additional research samples are usually taken at the same time as participants diagnostic biopsy, so it should not cause you additional risk or inconvenience. However, there may be occasions where you are asked to have another biopsy if the previously obtained samples are not good enough for research purposes. There may be additional risks that we do not expect or do not know about.

Where is the study run from?
Glasgow Royal Infirmary (UK)

When is the study starting and how long is it expected to run for?
April 2017 to March 2022

Who is funding the study?
1. CRUK (UK)
2. Celgene (UK)

Who is the main contact?
Ms Judith Dixon-Hughes (Public)
judith.dixon@glasgow.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Judith Dixon-Hughes

ORCID ID

http://orcid.org/0000-0002-5596-4400

Contact details

CRUK CTU Glasgow
Level 0 Beatson WoSCC
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
+44 141 301 7540
judith.dixon@glasgow.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

IRAS184216

Study information

Scientific title

Precision Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

Acronym

Precision Panc

Study hypothesis

The overall framework of Precision-Panc aims to accelerate stratified therapeutic development though co-ordination, data sharing and aligned decision-making. This UK-wide Master Protocol will enable the screening and molecular profiling of patients with pancreatic cancer, embedded within the standard diagnostic pathway to subsequent enrolment in available Pancreatic canceR Individualised Multi-arm Umbrella Study (PRIMUS) studies. PRIMUS is the set of clinical trials where patients may be recruited to the most suitable treatment studies based on their molecular phenotype and/or integrated with biomarker discovery and validation approaches. We aim to create a patient-focused environment where attractive trial options are offered to as many patients and their treating clinicians as possible. The aim is to identify the right trial for the patient, rather than current approaches where we search for patients for a specific trial. By offering a range of attractive options for patients and clinicians, we envisage significant increases in recruitment. In addition, Precision-Panc will also provide a platform for drug development in partnership with industry, by screening and identifying subgroup of patients with candidate biomarker of therapeutic responsiveness.

The outcomes of the patients will be recorded on the Master Protocol or the PRIMUS studies. Precision-Panc Master Protocol will serve not only as a molecular profiling platform for PRIMUS clinical trials, but also a translational research platform. The molecular profiling data generated along with the outcome data will be essential in the delineation of molecular mechanisms important in the pathophysiology of pancreatic cancer. This in turn will provide significant opportunities to understand the molecular pathology of pancreatic cancer better, and to identify candidate biomarkers for available therapeutic options and define therapeutic targets for novel drug development.

Ethics approval

West of Scotland REC 1, 27/09/2017, ref: 17/WS/0147

Study design

Interventional non randomised study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Diagnostic

Patient information sheet

See additional files

Condition

Pancreatic Cancer

Intervention

Patients with either suspected or confirmed pancreatic cancer are approached to take part in the study and given the Precision Panc Screening PIS. Participants are given time to consider trial participation and if they are willing to take part in the study they are screened onto the study. If the patient has suspected pancreatic cancer and are having a standard of care diagnostic biopsy, extra cores are taken at that time for the Precision Panc study. If pancreatic ductal adenocarcinoma is confirmed the patient are then given the registration PIS/consent which allows for molecular profiling to take place on the extra tissue taken for research. If the patient already has a diagnosis of pancreatic ductal adenocarcinoma they are asked to undergo and additional research biopsy for the study. All participants are also asked to provide a blood sample for research. The tissue (either the extra diagnostic tissue or the research biopsy) and blood sample are sent to Glasgow for molecular profiling and if enough tissue is available for profiling they may be eligible for an open PRIMUS study.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

To establish a mechanism and framework to recruit and screen patients with pancreatic cancer to perform molecular profiling, evaluation of circulating biomarkers and allow enrolment to Precision Panc PRIMUS studies. This will be measured by the number of patients screened and registered to the study and the number of patients where a molecular profile is obtained. The number of patients registered to Precision Panc who then go onto a PRIMUS study will also be measured

Secondary outcome measures

1. To assess the overall survival (OS) in patients enrolled in Precision-Panc and relate this to molecular profile information
2. To assess the safety of obtaining tumour biopsies suitable for molecular profiling within a standard patient treatment pathway
3. To establish a central repository of molecular profiles with accompanying phenotypic data and accompanying biospecimens for further translational research
4. To establish a dynamic platform for evaluation of circulating biomarkers to subsequently inform design of subsequent clinical studies

Overall trial start date

01/04/2017

Overall trial end date

30/03/2022

Reason abandoned

Eligibility

Participant inclusion criteria

1. Adult patients (age >16 years)
2. With either:
2.1. 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
2.2. Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants
3. Patient is willing and able to undergo tumour biopsy aimed at obtaining sufficient tissue for molecular profiling
4. Patient is deemed suitable to receive chemotherapy and/or radiotherapy, and/or surgery pending stage of disease at presentation
5. Signed informed consent for screening research tumour biopsy (Consent 1)
6. Signed informed consent for Precision-Panc Master Protocol molecular profiling (Consent 2)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2500-5000

Participant exclusion criteria

There is no participant exclusion criteria.

Recruitment start date

14/12/2017

Recruitment end date

29/03/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Glasgow Royal Infirmary
84 Castle Street
Glasgow
G4 0SF
United Kingdom

Sponsor information

Organisation

NHS Greater Glasgow and Clyde

Sponsor details

JB Russell House
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 OXH
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Charity

Funder name

CRUK

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Celgene

Alternative name(s)

Celgene Corporation

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

Location

United States of America

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from Judith Dixon at judith.dixon@glasgow.ac.uk

Intention to publish date

30/03/2023

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes