Why building a national registry for pituitary tumors?
Sellar tumors belong to the most common intracranial neoplasms. Pituitary adenomas account for the majority of these tumors and have an estimated prevalence of 17%. Nevertheless, most of these tumors remain undetected, unless they cause endocrinological syndromes, symptoms of local mass effect, or are found incidentally on neuroimaging. Therefore, the apparent clinical incidence is comparably low and the prolonged natural history has hindered efforts to evaluate long-term clinical outcomes. Care of these patients is often provided by larger tertiary specialist referral centers. The treatment of these pathologies demands an interdisciplinary network consisting of endocrinologists, neurosurgeons, radiooncologists, radiosurgeons, ophthalmologists, otorhinolaryngologists, neuropathologists and neuroradiologists. Each of these specialists contributes valuable information to optimize treatment of these patients. Therefore, networks with the goal of increasing the efficiency of the various diagnostics and therapies have been built in Switzerland. Nevertheless, a registry to collect biomedical data of pituitary patients is lacking in Switzerland. While in other European Countries established centers provided the base for nationwide databases (e.g. the German Acromegaly Registry or the German pituitary tumors registry), this is not the case in our country. The experience of these networks shows, that they were rapidly adopted by other centers and could be used as a resource for gaining experience on the long-term course of these patients. While due to the low incidence sufficient numbers of patients are hard to find for retrospective data analysis, this is automatically provided by these databases, resulting in resourceful scientific contributions.
What is SwissPit all about?
The overall objective of SwissPit is to describe the clinical course of patients with sellar pathologies by providing a Swiss tumor registry. The registry data provides details of the endocrinological, neurological, ophthalmological and oncological course of patients with pituitary lesions.
Who is a candidate for SwissPit and what data is collected?
Patients with the following pathologies are eligible for SwissPit: pituitary adenomas; craniopharyngiomas; Rathke’s cleft cysts; rare sellar lesions (e.g. metastases, pituizytoma, germinoma, inflammatory and infectious diseases of the pituitary). Patients with pathologies adjacent to the sellar region with secondary growth into the sella are not eligible. Every patient is informed before anonymization and inclusion. All the data entered into the registry are the result of routine clinical care. There are no specific terms to be fulfilled (e.g. minimum follow-up, additional visits). Data is be collected retro- and prospectively. Endocrinological, ophthalmological and neuroradiological work-up should be based on the established guidelines of the partaking centers and conducted or assisted by trained staff. Any patient is allowed to withdraw from participation. All the data already collected at time of withdrawal remains in the database. The data is collected in an electronic data capture system (secuTrial) running on a secure server maintained by the IT-department of the University Hospital Basel.
How to become a member?
Centers applying for a SwissPit membership have to have an active scientific interest in neuroendocrine pathologies. All partaking centers provide two local leaders: a neurosurgeon and an endocrinologist with a special interest in disorders of the pituitary gland. Applications for membership may be send to the project leader by using the contact form. Further details will be given thereafter.
Ethics & GCP.
Is SwissPit in accordance with Good Clinical Practice?
The content and proceedings of SwissPit have been approved by the ethical committee Nordwestschweiz (EKNZ). An ethical approval for conducting a retrospective trial based on the informations contained in SwissPit by the Kantonsspital Aarau has been given (no. 2015-375). The registry and all the resulting studies will be conducted in compliance with the current version of the Declaration of Helsinki, the ICH-GCP or ISO EN 14155 (as far as applicable) as well as all national legal and regulatory requirements.
Facts & Figures.
How far did we come?
Total number of patients recorded - January 31st 2016 until January 17th 2017: 321
Kantonsspital Aarau: 272 patients; Universitätsspital Basel: 49 patients