Risk of malignancy after stereotactic radiosurgery

Gamma Knife stereotactic radiosurgery is used worldwide to treat a number of different pathologies in the head. Most of these are non-cancerous (benign) tumours or vascular malformations. As with any radiation treatment, there is a theoretical risk of the tumour turning cancerous or the treated area developing a new cancer, often after a number of years, as a response to the treatment.

This study reviews the patients treated by the centre over the last 40 years to quantify the number of patients who develop a cancer after treatment. Any subsequent malignancy will be compared to the precise anatomical location of treatment and evaluated if the two are related. This gives the numbers of patients that may have a cancer caused by this treatment. This number will be compared with the ONS published national cancer incidence datasets to evaluate whether it is equivalent to that which would be expected in an equivalent untreated population.

The Data will be used for the purpose of a research project: Risk of malignancy after stereotactic radiosurgery.

The Primary aims of the research project are:

- To evaluate the risk of Gamma Knife Stereotactic Radiosurgery (GKSRS) in causing malignant transformation of previously benign intracranial tumours.

- To assess the risk of inducing new malignancies within or near the previously irradiated treatment field.

The Data will be used to answer the following questions:

- Is there an increased incidence of intracranial malignancy in patients treated with GKSRS compared to the general population

- Do any post-treatment malignancies occur within the anatomical area that received radiation

- Is there excess mortality in the treated cohort compared to national mortality statistics

- Does the presence of abnormal tumour suppressor genes (e.g., Neurofibromatosis type II (NFII) or Von Hippel-Lindau disease (VHL) influence the risk of malignancy after treatment

- How do the observed malignancy rates compare with predicted rates based on age, sex, and time-matched national cancer incidence data

Sheffield Teaching Hospital NHS Foundation Trust will transfer data to NHS England.

The data will consist of identifying details (specifically NHS Number, Date of Birth, Gender and a unique person ID) for the cohort to be linked with NHS England data.

NHS England will provide the relevant records from the Civil Registrations of Death and Cancer registration Datasets. The Data will contain no direct identifying data items but will contain a unique person ID which can be used to link the Data with other record level data already held by the Sheffield Teaching Hospital NHS Foundation Trust.

The Data will not be transferred to any other location.

The Data will be stored on servers at Sheffield Teaching Hospital NHS Foundation Trust only

The Data will be accessed onsite at the premises of Sheffield Teaching Hospital NHS Foundation Trust.

The Data will not leave England and Wales at any time

Access is restricted to employees of University of Sheffield Teaching Hospital NHS Foundation Trust who have authorisation from the Principal Investigator.

All personnel accessing the Data have been appropriately trained in data protection and confidentiality.

The Data will be linked at person record level with the data obtained from patient treatments held in the database at the research unit of the Sheffield Teaching Hospital NHS Foundation Trust.

There will be no requirement and no attempt to reidentify individuals when using the Data.

The expected outputs of the processing will be:

A report of findings to NeuroCare Charity and Neurosciences Executive Group at Sheffield Teaching Hospitals following data analysis and write-up

Submissions to peer-reviewed journals, targeting international journals in neurosurgery or oncology

Presentations to professional groups (e.g., neurosurgeons, radiologists) and patient groups (e.g., support organisations for brain tumour patients)

Presentations at local, national, and international conferences on neurosurgery or oncology

The outputs will not contain NHS England Data and will only contain aggregated information with small numbers suppressed as appropriate in line with the relevant disclosure rules for the dataset(s) from which the information was derived.

The outputs will be communicated to relevant recipients through the following dissemination channels:

- Journals

- Workshops involving professional groups (e.g., neurosurgeons, radiologists) and patient support organisations.

- Public reports

- Presentations at appropriate conferences, dissemination at local, national, and international meetings, including both clinical and patient-led events.

- Direct bilateral engagement with referring clinicians and stakeholders involved in stereotactic radiosurgery services.

- Public promotion of the research through conference presentations, patient information leaflets, and engagement with support groups.

- Reports aimed at patients. Findings will be shared in formats suitable for patient understanding, including updates to patient information leaflets and discussions during clinic visits.

The findings of this research study are expected to contribute to evidence-based decision-making for policy-makers, local decision-makers such as doctors, and patients to inform best practice to improve the care, treatment and experience of health care users relevant to the subject matter of the study.

The use of the data could:

- help the system to better understand the health and care needs of populations, specifically the long-term outcomes of Gamma Knife Stereotactic Radiosurgery.

- lead to the identification or improvement of treatments or interventions, or health and care system design to improve health and care outcomes or experience by evaluating the risk of malignant transformation or new malignancies post-GKSRS.

- advance understanding of regional and national trends in health and social care needs.

- advance understanding of the need for, or effectiveness of, preventative health and care measures for patients treated with Gamma Knife Stereotactic Radiosurgery by highlighting areas of good practice or potential risks that require further attention.

- inform planning health services and programmes, for example to improve equity of access, experience and outcomes by analysing national patterns in post-radiosurgery outcomes.

- inform decisions on how to effectively allocate and evaluate funding according to health needs to guide future service design, particularly in stereotactic radiosurgery centres, and support decisions about ongoing monitoring and follow-up protocols.

- support knowledge creation or exploratory research (and the innovations and developments that might result from that exploratory work).

Yielded Benefits is not a requirement for new applications.