Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Precision-Panc Master Protocol: Personalising Treatment For Pancreatic Cancer

Conditions
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Neoplasms Pancreatic

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


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Biopsy Material Required for Registration<br>The Precision-Panc Master Protocol aims to recruit, consent and screen patients with pancreatic cancer | Other: Patients with suspected or confirmed pancreatic cancer will be be asked to provide biopsy material for molecular profiling<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |