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| Name | Class |
|---|---|
| Cancer Research UK | OTHER |
| NHS Greater Glasgow and Clyde | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Biopsy Material Required for Registration | Other | The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling | 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 |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progression Free Survival | To assess the progression-free survival (PFS) in patients enrolled in Precision-Panc and relate this to molecular profile information | At time of progression (this is estimated at around 6-9 months for this group of patients) |
Inclusion Criteria:
Adult patients (age >16 years).
Either:
Or
o Histologically or cytologically confirmed pancreatic ductal adenocarcinoma and its variants.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Judith Dixon-Hughes | Contact | 01413302718 | judith.dixon@glasgow.ac.uk |
| Name | Affiliation | Role |
|---|---|---|
| David Chang | University of Glasgow | Principal Investigator |
| Juan Valle | University of Manchester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aberdeen Royal Infirmary | Recruiting | Aberdeen | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37378896 | Derived | 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. |
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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.
On study completion
Request to TMG
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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.
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|
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 |
| Northern Ireland Cancer Centre | Recruiting | Belfast | United Kingdom |
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| Queen Elizabeth Hospital | Recruiting | Birmingham | United Kingdom |
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| Royal Bournemouth Hospital | Recruiting | Bournemouth | United Kingdom |
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| Bristol Oncology Centre | Recruiting | Bristol | United Kingdom |
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| Addenbrooke's Hospital | Recruiting | Cambridge | United Kingdom |
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| Castle Hill Hospital | Recruiting | Cottingham | United Kingdom |
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| Ninewells Hospital | Recruiting | Dundee | United Kingdom |
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| Western General | Recruiting | Edinburgh | United Kingdom |
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| Glasgow Royal Infirmary | Recruiting | Glasgow | United Kingdom |
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| Huddersfield Royal Infirmary | Recruiting | Huddersfield | United Kingdom |
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| Raigmore Hospital | Recruiting | Inverness | United Kingdom |
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| St James's Hospital | Recruiting | Leeds | United Kingdom |
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| Royal Liverpool Hospital | Recruiting | Liverpool | United Kingdom |
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| Guy's Hospital | Recruiting | London | United Kingdom |
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| Imperial College Healthcare Trust | Recruiting | London | United Kingdom |
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| King's College Hospital | Recruiting | London | United Kingdom |
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| Royal Free London Hospital | Recruiting | London | United Kingdom |
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| Royal Marsden Hospital | Recruiting | London | United Kingdom |
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| St Bart's Hospital | Recruiting | London | United Kingdom |
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| St George's Hospital | Recruiting | London | United Kingdom |
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| University College London Hospital | Recruiting | London | United Kingdom |
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| Manchester Royal Infirmary | Recruiting | Manchester | United Kingdom |
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| The Christie, Manchester | Recruiting | Manchester | United Kingdom |
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| Milton Keynes Hospital | Recruiting | Milton Keynes | United Kingdom |
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| Freeman Hospital | Recruiting | Newcastle | United Kingdom |
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| Nottingham Hospitals NHS Trust | Recruiting | Nottingham | United Kingdom |
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| Churchill Hospital | Recruiting | Oxford | United Kingdom |
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| Pool Hospital | Recruiting | Poole | United Kingdom |
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| Weston Park | Recruiting | Sheffield | United Kingdom |
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| University Hospital Southampton | Recruiting | Southampton | United Kingdom |
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| Morriston Hospital | Recruiting | Swansea | United Kingdom |
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| Royal Albert Edward Infirmary | Recruiting | Wigan | United Kingdom |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
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