Clinical trial NCT04161417: Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer
Official title: Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neoplasms Pancreatic
Lead sponsor: University of Glasgow
Sponsor class: OTHER
Collaborators: name: Cancer Research UK
name: NHS Greater Glasgow and Clyde
First posted: 2019-11-13
Enrollment: 2500
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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 purpose: SCREENING

Brief summary: 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.


Eligibility criteria: 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).

Primary outcomes:
measure: Proving that patients with pancreatic cancer can have their tissue molecularly assessed and be followed up in a clinical trial setting
timeFrame: At end of study (5 years)
Secondary outcomes:
measure: Overall Survival
timeFrame: From date of registration until date of death from any cause, assessed up to 5 years
measure: Number of participants with biopsy related adverse events as assesed by CTCAE v4.03
timeFrame: At time of biopsy, usually within one week of screening
Other outcomes:
measure: Progression Free Survival
timeFrame: At time of progression (this is estimated at around 6-9 months for this group of patients)
Locations:
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary
city: Belfast
country: United Kingdom
facility: Northern Ireland Cancer Centre
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Bournemouth
country: United Kingdom
facility: Royal Bournemouth Hospital
city: Bristol
country: United Kingdom
facility: Bristol Oncology Centre
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital
city: Cottingham
country: United Kingdom
facility: Castle Hill Hospital
city: Dundee
country: United Kingdom
facility: Ninewells Hospital
city: Edinburgh
country: United Kingdom
facility: Western General
city: Glasgow
country: United Kingdom
facility: Glasgow Royal Infirmary
city: Huddersfield
country: United Kingdom
facility: Huddersfield Royal Infirmary
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Leeds
country: United Kingdom
facility: St James's Hospital
city: Liverpool
country: United Kingdom
facility: Royal Liverpool Hospital
city: London
country: United Kingdom
facility: Guy's Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare Trust
city: London
country: United Kingdom
facility: King's College Hospital
city: London
country: United Kingdom
facility: Royal Free London Hospital
city: London
country: United Kingdom
facility: Royal Marsden Hospital
city: London
country: United Kingdom
facility: St Bart's Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: University College London Hospital
city: Manchester
country: United Kingdom
facility: Manchester Royal Infirmary
city: Manchester
country: United Kingdom
facility: The Christie, Manchester
city: Milton Keynes
country: United Kingdom
facility: Milton Keynes Hospital
city: Newcastle
country: United Kingdom
facility: Freeman Hospital
city: Nottingham
country: United Kingdom
facility: Nottingham Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Churchill Hospital
city: Poole
country: United Kingdom
facility: Pool Hospital
city: Sheffield
country: United Kingdom
facility: Weston Park
city: Southampton
country: United Kingdom
facility: University Hospital Southampton
city: Swansea
country: United Kingdom
facility: Morriston Hospital
city: Wigan
country: United Kingdom
facility: Royal Albert Edward Infirmary
Study officials:
affiliation: University of Glasgow
name: David Chang
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Manchester
name: Juan Valle
role: PRINCIPAL_INVESTIGATOR
References: