Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

Neoplasms Pancreatic Clinical Trial

Official title:

Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04161417
• Other study ID #: GN17on293
• Status: Recruiting
• Phase: N/A
• Start date: November 28, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2024
• Source: University of Glasgow
• Contact: Judith Dixon-Hughes
• Phone: 01413302718
• Email: judith.dixon[@]glasgow.ac.uk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Neoplasms Pancreatic

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Aberdeen Royal Infirmary	Aberdeen
United Kingdom	Northern Ireland Cancer Centre	Belfast
United Kingdom	Queen Elizabeth Hospital	Birmingham
United Kingdom	Royal Bournemouth Hospital	Bournemouth
United Kingdom	Bristol Oncology Centre	Bristol
United Kingdom	Addenbrooke's Hospital	Cambridge
United Kingdom	Castle Hill Hospital	Cottingham
United Kingdom	Ninewells Hospital	Dundee
United Kingdom	Western General	Edinburgh
United Kingdom	Glasgow Royal Infirmary	Glasgow
United Kingdom	Huddersfield Royal Infirmary	Huddersfield
United Kingdom	Raigmore Hospital	Inverness
United Kingdom	St James's Hospital	Leeds
United Kingdom	Royal Liverpool Hospital	Liverpool
United Kingdom	Guy's Hospital	London
United Kingdom	Imperial College Healthcare Trust	London
United Kingdom	King's College Hospital	London
United Kingdom	Royal Free London Hospital	London
United Kingdom	Royal Marsden Hospital	London
United Kingdom	St Bart's Hospital	London
United Kingdom	St George's Hospital	London
United Kingdom	University College London Hospital	London
United Kingdom	Manchester Royal Infirmary	Manchester
United Kingdom	The Christie, Manchester	Manchester
United Kingdom	Milton Keynes Hospital	Milton Keynes
United Kingdom	Freeman Hospital	Newcastle
United Kingdom	Nottingham Hospitals NHS Trust	Nottingham
United Kingdom	Churchill Hospital	Oxford
United Kingdom	Pool Hospital	Poole
United Kingdom	Weston Park	Sheffield
United Kingdom	University Hospital Southampton	Southampton
United Kingdom	Morriston Hospital	Swansea
United Kingdom	Royal Albert Edward Infirmary	Wigan

Sponsors (3)

Lead Sponsor	Collaborator
Judith Dixon-Hughes	Cancer Research UK, NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Primary	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	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
Secondary	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