Safe People
Lead applicant organisation name	University Hospitals Birmingham NHS Foundation Trust

Safe Projects
Project title	Vitamin D in Pancreatic Cancer (VitPanc-1): A retrospective single-centre cohort study assessing the relationship between preoperative serum 25-OH vitamin D levels and histological differentiation in resected pancreatic cancer
Lay summary	The pancreas is an organ at the back of the tummy that makes enzymes to digest food and hormones such as insulin. Pancreatic cancer is a rare but aggressive cancer, and it can be difficult to treat. Pancreatic cancer is often diagnosed after the cancer has already spread and can not be treated with surgery. Even if a patient can have surgery, most often this does not cure the cancer and it comes back. We want to find new ways to make the surgery more likely to cure patients. Fluorescence-guided surgery uses fluorescent drugs that make cancer cells glow brightly. This can make surgery more effective by helping surgeons to see the cancer more clearly during the operation. One such fluorescent drug is called 5-aminolevulinic acid (ALA). This drug is already used in brain cancer surgery, and we want to conduct studies to see if it can be used in pancreatic cancer surgery too. The VitPanc-1 study will review data from patients who had pancreatic cancer at UHB during the last 10 years, to investigate if there is a link between a patients’ vitamin D level pre-surgery and how abnormal their pancreatic cancer looked under the microscope. We will not contact patients for this study, or ask them to do anything. We will only be collecting data that was already collected as part of their normal clinical care, such as information from blood results. With this information, we will plan a study in the future to give patients vitamin D supplements just before their operation, to see if this makes their cancer less abnormal under the microscope. If it does, we will then develop studies using ALA for fluorescence-guided surgery in pancreatic cancer.
Public benefit statement	At present, over 80% of patients who undergo pancreatic cancer surgery have their cancer recur. Palliative chemotherapy can extend life by a few months, but is not particularly effective. Clearly a 20% cure rate from surgery is inadequate, and other approaches are needed. Studies in ALA-guided glioma resections (brain cancer) showed significantly improved recurrence-free survival compared to surgery without ALA. ALA is also a photodynamic therapy (PDT) drug, which can kill cancer cells when shining a laser on cells treated with ALA. The eventual aim would be to perform vitamin D-enhanced ALA-guided pancreatic cancer surgery with laser treatment of the pancreatic bed to prevent cancer recurrence. As 20% of patients who get recurrence after pancreatic cancer surgery get local-only recurrence (i.e. just around the area where the cancer was in the pancreas), in theory these are the patients at highest chance of being cured using this extra technology. If we can improve survival from pancreatic cancer using this method, there are clear patient benefits to those undergoing pancreatic cancer surgery.
Latest approval date	20/11/2024

Safe Data
Dataset(s) name	PATHWAY Research Data Hub: PWY020 dataset

Safe Setting
Access type	Data released via Letter of Authorisation. All researchers have received training in the care, use and protection of personal data, enabling them to comply with their responsibilities under the Data Protection Act.

Safe Outputs
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