Precision Panc: Advancing personalised medicine treatment strategies for pancreatic cancer
| ISRCTN | ISRCTN14879538 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14879538 |
| IRAS number | 184216 |
| Secondary identifying numbers | IRAS184216 |
- Submission date
- 22/01/2018
- Registration date
- 29/01/2018
- Last edited
- 20/09/2021
- Recruitment status
- Suspended
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Public
CRUK CTU Glasgow
Level 0 Beatson WoSCC
1053 Great Western Road
Glasgow
G12 0YN
United Kingdom
 ORCID ID |
0000-0002-5596-4400 |
|---|---|
| Phone | +44 141 301 7540 |
| judith.dixon@glasgow.ac.uk |
Study information
| Study design | Interventional non randomised study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | See additional files |
| Scientific title | Precision Panc Master Protocol: Personalising Treatment for Pancreatic Cancer |
| Study 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(s) | West of Scotland REC 1, 27/09/2017, ref: 17/WS/0147 |
| 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 |
| Primary outcome measure | 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 study start date | 01/04/2017 |
| Overall study end date | 30/03/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 2500-5000 |
| 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 exclusion criteria | There is no participant exclusion criteria. |
| Recruitment start date | 14/12/2017 |
| Recruitment end date | 29/03/2022 |
Locations
Countries of recruitment
- England
- Northern Ireland
- Scotland
- United Kingdom
Study participating centres
Glasgow
G4 0SF
United Kingdom
AB25 2ZN
United Kingdom
SW3 6JJ
United Kingdom
NW1 2BU
United Kingdom
CB2 0QQ.
United Kingdom
M20 4BX
United Kingdom
S10 2SJ
United Kingdom
S10 2SJ
United Kingdom
SW7 2BX
United Kingdom
NG5 1PB
United Kingdom
NW3 2QG
United Kingdom
DD2 1UB
United Kingdom
SW17 0QT
United Kingdom
SO16 6YD
United Kingdom
B15 2WB
United Kingdom
SE5 9RS
United Kingdom
OX3 7LE
United Kingdom
HU16 5JQ
United Kingdom
BH15 2JB
United Kingdom
NE7 7DN
United Kingdom
BH7 7DW
United Kingdom
WN1 2NN
United Kingdom
BT9 7JL
United Kingdom
EH4 2XU
United Kingdom
IV2 3DZ
United Kingdom
L7 8XP
United Kingdom
HD3 3EA
United Kingdom
Sponsor information
Hospital/treatment centre
JB Russell House
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 OXH
Scotland
United Kingdom
"ROR" |
https://ror.org/05kdz4d87 |
|---|
Funders
Funder type
Charity
No information available
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Celgene Corporation
- Location
- United States of America
Results and Publications
| Intention to publish date | 30/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 06/10/2017 | 02/04/2019 | No | No | |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN14879538_Protocol_Version 2_06Oct2017_Clean.pdf
- Uploaded 02/04/2019
Editorial Notes
20/09/2021: Internal review.
04/06/2021: Recruitment for this study is no longer paused and the following changes have been made:
1. The trial website has been added.
2. The trial participating centres "Aberdeen Royal Infirmary", "Royal Marsden Hospital", "UCLH", "Addenbrookes Hospital", "Christie, Manchester", "Weston", "Bristol Oncology Centre", "Imperial College London", "Nottingham University Healthcare Trust", "Royal Free London Hospital", "Ninewells Hospital", "St George's Hospital", "Southampton University Hospital", "Queen Elizabeth Hospital Birmingham", "King's College Hospital", "Churchill Hospital", "Castle Hill Hospital", "Poole Hospital", "Freeman Hospital", "Royal Bournemouth Hospital", "Royal Albert Edward Infirmary", "Northern Ireland Cancer Centre", "Western General Infirmary", "Raigmore Hospital", "Royal Liverpool Hospital", and "Huddersfield Royal Infirmary" have been added.
15/04/2020: Due to current public health guidance, recruitment for this study has been paused.
02/04/2019: Uploaded protocol (not peer reviewed).
