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2017-11-28
2025-12-31
2025-12-31
2500
NCT04161417
University of Glasgow
University of Glasgow
INTERVENTIONAL
Precision-Panc Master Protocol: Personalising Treatment for Pancreatic Cancer
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.
N/A
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-10-24 | N/A | 2024-02-07 |
2019-11-11 | N/A | 2024-02-08 |
2019-11-13 | N/A | 2024-02 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Screening
Allocation:
Na
Interventional Model:
Single Group
Masking:
None
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| OTHER: Biopsy Material Required for Registration 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
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
|
Study Contact Name: Judith Dixon-Hughes Phone Number: 01413302718 Email: judith.dixon@glasgow.ac.uk |
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
16 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
