Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

Judith Dixon-Hughes

Status

Enrolling

Conditions

Neoplasms Pancreatic

Treatments

Other: Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling

Study type

Interventional

Funder types

Other

Identifiers

NCT04161417

GN17on293

Details and patient eligibility

About

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.

Enrollment

2,500 estimated patients

Sex

All

Ages

16+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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).

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).