Frontiers in Pediatrics (Jul 2022)
Development and implementation of the AIDA International Registry for patients with Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis syndrome
- Francesca Della Casa,
- Antonio Vitale,
- Marco Cattalini,
- Francesco La Torre,
- Giovanna Capozio,
- Giovanna Capozio,
- Emanuela Del Giudice,
- Maria Cristina Maggio,
- Giovanni Conti,
- Maria Alessio,
- Benson Ogunjimi,
- Benson Ogunjimi,
- Benson Ogunjimi,
- Benson Ogunjimi,
- Gaafar Ragab,
- Gaafar Ragab,
- Giacomo Emmi,
- Emma Aragona,
- Teresa Giani,
- Giuseppe Lopalco,
- Paola Parronchi,
- Farhad Shahram,
- Elena Verrecchia,
- Elena Verrecchia,
- Francesca Ricci,
- Fabio Cardinale,
- Silvia Di Noi,
- Rossana Nuzzolese,
- Riccardo Lubrano,
- Serena Patroniti,
- Roberta Naddei,
- Vito Sabato,
- Mohamed A. Hussein,
- Laura Dotta,
- Violetta Mastrorilli,
- Stefano Gentileschi,
- Abdurrahman Tufan,
- Valeria Caggiano,
- Mohamed Tharwat Hegazy,
- Mohamed Tharwat Hegazy,
- Jurgen Sota,
- Ibrahim A. Almaghlouth,
- Ibrahim A. Almaghlouth,
- Amr Ibrahim,
- Ewa Wiȩsik-Szewczyk,
- Burcugul Ozkiziltas,
- Salvatore Grosso,
- Micol Frassi,
- Maria Tarsia,
- Rosa Maria R. Pereira,
- Maged Taymour,
- Carla Gaggiano,
- Sergio Colella,
- Claudia Fabiani,
- Maria Morrone,
- Piero Ruscitti,
- Bruno Frediani,
- Veronica Spedicato,
- Henrique A. Mayrink Giardini,
- Alberto Balistreri,
- Donato Rigante,
- Donato Rigante,
- Luca Cantarini
Affiliations
- Francesca Della Casa
- Section of Clinical Immunology, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy
- Antonio Vitale
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- Marco Cattalini
- Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy
- Francesco La Torre
- Pediatric Rheumatology Center, Department of Pediatrics, Ospedale “Giovanni XXIII”, AOU Consorziale Policlinico, Bari, Italy
- Giovanna Capozio
- Department of Life Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
- Giovanna Capozio
- Meyer Children's University Hospital, Florence, Italy
- Emanuela Del Giudice
- Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Polo Pontino, Italy
- Maria Cristina Maggio
- University Department Pro.Sa.M.I. “G. D'Alessandro”, University of Palermo, Palermo, Italy
- Giovanni Conti
- Pediatric Nephrology and Rheumatology Unit, AOU G Martino, Messina, Italy
- Maria Alessio
- 0Pediatric Rheumatology Unit, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy
- Benson Ogunjimi
- 1AUDACIS, Antwerp Unit for Data Analysis and Computation in Immunology and Sequencing, University of Antwerp, Antwerp, Belgium
- Benson Ogunjimi
- 2Antwerp Center for Translational Immunology and Virology (ACTIV), Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium
- Benson Ogunjimi
- 3Department of Paediatrics, Antwerp University Hospital, Antwerp, Belgium
- Benson Ogunjimi
- 4Center for Health Economics Research and Modeling Infectious Diseases (CHERMID), Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium
- Gaafar Ragab
- 5Rheumatology and Clinical Immunology Unit, Internal Medicine Department, Faculty of Medicine, Cairo University, Giza, Egypt
- Gaafar Ragab
- 6Faculty of Medicine, Newgiza University (NGU), Giza, Egypt
- Giacomo Emmi
- 7Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
- Emma Aragona
- 8Division of Gastroenterology, Ospedali Riuniti Villa Sofia-Vincenzo Cervello, Palermo, Italy
- Teresa Giani
- 9ASST G. Pini-CTO, Department of Clinical Sciences and Community Health, Research Center for Adult and Pediatric Rheumatic Diseases, University of Milan, Milan, Italy
- Giuseppe Lopalco
- 0Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
- Paola Parronchi
- 7Department of Experimental and Clinical Medicine, University of Florence, Florence, Italy
- Farhad Shahram
- 1Behcet's Disease Unit, Rheumatology Research Center, Shariati Hospital, Tehran University of Medical Sciences, Tehran, Iran
- Elena Verrecchia
- 2Department of Aging, Neurological, Orthopedic and Head and Neck Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy
- Elena Verrecchia
- 3Rare Diseases and Periodic Fevers Research Centre, Università Cattolica Sacro Cuore, Rome, Italy
- Francesca Ricci
- Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy
- Fabio Cardinale
- Pediatric Rheumatology Center, Department of Pediatrics, Ospedale “Giovanni XXIII”, AOU Consorziale Policlinico, Bari, Italy
- Silvia Di Noi
- Department of Life Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
- Rossana Nuzzolese
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- Riccardo Lubrano
- Department of Maternal Infantile and Urological Sciences, Sapienza University of Rome, Polo Pontino, Italy
- Serena Patroniti
- Pediatric Nephrology and Rheumatology Unit, AOU G Martino, Messina, Italy
- Roberta Naddei
- 0Pediatric Rheumatology Unit, Department of Translational Medical Sciences, University of Naples Federico II, Naples, Italy
- Vito Sabato
- 4Immunology Allergology Rheumatology University of Antwerp and Antwerp University Hospital, Antwerp, Belgium
- Mohamed A. Hussein
- 5Rheumatology and Clinical Immunology Unit, Internal Medicine Department, Faculty of Medicine, Cairo University, Giza, Egypt
- Laura Dotta
- Pediatric Clinic, University of Brescia and Spedali Civili di Brescia, Brescia, Italy
- Violetta Mastrorilli
- Pediatric Rheumatology Center, Department of Pediatrics, Ospedale “Giovanni XXIII”, AOU Consorziale Policlinico, Bari, Italy
- Stefano Gentileschi
- 5Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy
- Abdurrahman Tufan
- 6Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Gazi University, Ankara, Turkey
- Valeria Caggiano
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- Mohamed Tharwat Hegazy
- 5Rheumatology and Clinical Immunology Unit, Internal Medicine Department, Faculty of Medicine, Cairo University, Giza, Egypt
- Mohamed Tharwat Hegazy
- 6Faculty of Medicine, Newgiza University (NGU), Giza, Egypt
- Jurgen Sota
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- Ibrahim A. Almaghlouth
- 7Rheumatology Unit, Department of Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia
- Ibrahim A. Almaghlouth
- 8College of Medicine Research Center, College of Medicine, King Saud University, Riyadh, Saudi Arabia
- Amr Ibrahim
- 9International Organization for Migration, Cairo, Egypt
- Ewa Wiȩsik-Szewczyk
- 0Department of Internal Medicine, Pulmonology, Allergy and Clinical Immunology, Central Clinical Hospital of the Ministry of National Defence, Military Institute of Medicine, Warsaw, Poland
- Burcugul Ozkiziltas
- 6Division of Rheumatology, Department of Internal Medicine, Faculty of Medicine, Gazi University, Ankara, Turkey
- Salvatore Grosso
- 1Clinical Paediatrics, Department of Molecular Medicine and Development, University of Siena, Siena, Italy
- Micol Frassi
- 2Rheumatology and Clinical Immunology, Spedali Civili and Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy
- Maria Tarsia
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- Rosa Maria R. Pereira
- 3Rheumatology Division, Hospital das Clinicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
- Maged Taymour
- 4Ministry of Health, Al Mounira Hospital, Cairo, Egypt
- Carla Gaggiano
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- Sergio Colella
- 0Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
- Claudia Fabiani
- 5Ophthalmology Unit, Department of Medicine, Surgery and Neurosciences, University of Siena, Siena, Italy
- Maria Morrone
- 0Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
- Piero Ruscitti
- 6Rheumatology Unit, Department of Biotechnological & Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy
- Bruno Frediani
- 5Unit of Rheumatology, Azienda Ospedaliero-Universitaria Senese, Siena, Italy
- Veronica Spedicato
- 0Rheumatology Unit, Department of Emergency and Organ Transplantation, University of Bari, Bari, Italy
- Henrique A. Mayrink Giardini
- 3Rheumatology Division, Hospital das Clinicas (HCFMUSP), Faculdade de Medicina, Universidade de São Paulo, São Paulo, Brazil
- Alberto Balistreri
- 7Bioengineering and Biomedical Data Science Lab, Department of Medical Biotechnologies, University of Siena, Siena, Italy
- Donato Rigante
- Department of Life Sciences and Public Health, Fondazione Policlinico Universitario A. Gemelli IRCCS, Rome, Italy
- Donato Rigante
- 3Rare Diseases and Periodic Fevers Research Centre, Università Cattolica Sacro Cuore, Rome, Italy
- Luca Cantarini
- Research Center of Systemic Autoinflammatory Diseases and Behçet's Disease Clinic, Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena, Italy
- DOI
- https://doi.org/10.3389/fped.2022.930305
- Journal volume & issue
-
Vol. 10
Abstract
ObjectiveAim of this paper is to illustrate the methodology, design, and development of the AutoInflammatory Disease Alliance (AIDA) International Registry dedicated to patients with the Periodic Fever, Aphthous stomatitis, Pharyngitis, and cervical Adenitis (PFAPA) syndrome.MethodsThis is a physician-driven, non-population- and electronic-based registry proposed to gather real-world demographics, clinical, laboratory, instrumental and socioeconomic data from PFAPA patients. Data recruitment is realized through the on-line Research Electronic Data Capture (REDCap) tool. This registry is thought to collect standardized information for clinical research leading to solid real-life evidence. The international scope and the flexibility of the registry will facilitate the realization of cutting-edge study projects through the constant updating of variables and the possible merging and transfer of data between current and future PFAPA registries.ResultsA total of 112 centers have already been involved from 23 countries and 4 continents starting from August 24th, 2021, to April 6th, 2022. In total 56/112 have already obtained the formal approval from their local Ethics Committees. The platform counts 321 users (113 principal investigators, 203 site investigators, two lead investigators, and three data managers). The registry collects retrospective and prospective data using 3,856 fields organized into 25 instruments, including PFAPA patient's demographics, medical histories, symptoms, triggers/risk factors, therapies, and impact on the healthcare systems.ConclusionsThe development of the AIDA International Registry for PFAPA patients will enable the on-line collection of standardized data prompting real-life studies through the connection of worldwide groups of physicians and researchers. This project can be found on https://clinicaltrials.gov NCT 05200715.
Keywords
- autoinflammatory diseases
- international registry
- personalized medicine
- PFAPA syndrome
- precision medicine
- rare disease
