Head and Neck Paraganglioma (HNPGL) Registry: A study protocol for prospective data collection in patients with Head and Neck Paragangliomas

• Published in: PloS one Vol. 19; no. 7; p. e0307311
• Main Authors: de Bresser, Carolijn J M, van Nesselrooij, Bernadette P M, van Treijen, Mark J C, Braat, Arthur J A T, de Ridder, Mischa, Stokroos, Robert J, de Bree, Remco, de Borst, Gert J, Rijken, Johannes A, Petri, Bart-Jeroen
• Format: Journal Article
• Language: English
• Published: United States Public Library of Science 25.07.2024; Public Library of Science (PLoS)
• Subjects: Biology and Life Sciences; Book publishing; Cancer; Case reports; Collaboration; Committees; Computer and Information Sciences; Consent; Data Collection; Data entry; Ethics; Exercise; Female; General Data Protection Regulation; Head & neck cancer; Head and neck; Head and Neck Neoplasms - diagnosis; Head and Neck Neoplasms - therapy; Health care facilities; Health services; Hospitals; Humans; Inclusion; Informed consent; Iodine; Male; Medical diagnosis; Medical research; Medicine and Health Sciences; Mortality; Oncology; Otolaryngology; Paraganglioma; Paraganglioma - diagnosis; Paraganglioma - therapy; Patient Reported Outcome Measures; Patients; Physical activity; Prospective Studies; Quality of Life; Questionnaires; Radiation therapy; Registries; Research and Analysis Methods; Study Protocol; Surgeons; Surveys and Questionnaires; Tumors; Vascular surgery; United States
• DOI: 10.1371/journal.pone.0307311
• ISSN: 1932-6203

There is a lack of comprehensive and uniform data on head and neck paragangliomas (HNPGLs), and research is challenging due to its rarity and the involvement of multiple medical specialties. To improve current research data collection, we initiated the Head and Neck Paraganglioma Registry (HNPGL Registry). The aim of the HNPGL Registry is to a) collect extensive data on all HNPGL patients through a predefined protocol, b) give insight in the long term outcomes using patient reported outcome measures (PROMs), c) create uniformity in the diagnostic and clinical management of these conditions, and thereby d) help provide content for future (randomized) research. The HNPGL Registry is designed as a prospective longitudinal observational registry for data collection on HNPGL patients and carriers of (likely) pathogenic variants causative of HNPGLs. All patients, regardless of the received treatment modality, can be included in the registry after informed consent is obtained. All relevant data regarding the initial presentation, diagnostics, treatment, and follow-up will be collected prospectively in an electronic case report form. In addition a survey containing the EuroQol 5D-5L (EQ-5D-5L), European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30), Modified Fatigue Impact Scale (MFIS), Short QUestionnaire to Assess Health-enhancing physical activity (SQUASH), Cancer Worry Scale (CWS) and Hospital Anxiety and Depression Scale (HADS) will be sent periodically. The registry protocol was approved by the Medical Ethical Review Board of the University Medical Center Utrecht. The HNPGL Registry data will be used to further establish the optimal management for HNPGL patients and lay the foundation for guideline recommendations and the outline of future research.