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Institution of an Italian Multicenter Database of Patients With Multiple Endocrine Neoplasia Type 1 (MENNET1 Database)
Sponsor: F.I.R.M.O. - Fondazione Italiana Ricerca sulle Malattie dell'Osso - Ente del Terzo Settore
Summary
The goal of this observational study is to create, manage and analyze a retro-prospective multicenter national database of patients diagnosed with multiple endocrine neoplasia type 1 (MEN1) syndrome (including genetic, clinical and/or familiar diagnosis), aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, and therapeutic data in a relatively high number of patients with this rare inherited endocrine tumor syndrome in Italy. The study will include 33 specialist clinical centers of endocrinology, pediatric endocrinology, pediatrics, and endocrine surgery, located throughout the Italian territory, and to which patients refer from all the 20 regions of Italy. Data will be collected over time, both in retrospective and prospective manners, during the 10-year average duration of the study, starting from the recruiting visit (basal visit) and then during each follow-up visits patients will undergo for the control of disease at the recruiting clinical centers, allowing for an epidemiological evaluation of prevalence and incidence of MEN1 in Italy, collecting detailed clinical history of the disease in enrolled patients, and refining and deepening medical knowledge in the field of this rare inherited endocrine tumor syndrome, and, thus, to be able to define optimal tailored diagnostic, clinical, and therapeutic management of patients, improving their quality of life. Collected data will include both the most classic traits of the pathology and the less common ones. The main aspects this observational study aims to assess and clarify are: 1. Evaluation of prevalence and incidence of MEN1 in Italy. 2. Clinical characterization of MEN1 phenotypes, through both cross-sectional and longitudinal analyses of collected data, and also based on MEN1 mutation types and location. 3. Evaluation of the over time prevalence of bone mass loss, osteopenia, osteoporosis and fragility fractures in patients with MEN1, with and without primary hyperparathyroidism, globally and also based on gender and age. 4. Over time evaluation of responses to surgical and pharmacological therapies in in patients MEN1. 5. Evaluation of dietary habits in MEN1 patients, by filling out a specific questionnaire at the time of the study recruitment. 6. Evaluation of quality of life and accessibility to specialist medical centers and to surgical and pharmacological therapies on the Italian territory by patients affected by MEN1 syndrome, globally and according to the region of residence, by filling out a specific self-evaluation questionnaire at the time of the study recruitment. The study will include a single cohort of female and male patients of any age, diagnosed with MEN1 syndrome (including either genetic, clinical and/or familiar diagnosis). The study does not include either any control group/comparison group or healthy volunteers. The study itself does not involve any medical intervention or drug administration. Surgical and pharmacological treatments for which data on response to therapy will be collected in the database, are those commonly employed for the control/treatment of MEN1 tumors and related symptoms, regardless of patients' inclusion in this observational study.
Official title: Creation, Management and Analysis of a National Database of Patients With Multiple Endocrine Neoplasia Type 1 (MENNET1 Database)
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2025-06-01
Completion Date
2035-05-31
Last Updated
2025-01-27
Healthy Volunteers
No
Conditions
Locations (33)
Dipartimento di Scienze Cliniche e Biologiche, Università di Torino, UO di Medicina Interna-Endocrinologia AOU San Luigi Gonzaga
Orbassano, Torino, Italy
Ambulatorio Tumori Neuro-Endocrini, Unità Operativa Complessa di Oncologia Medica Universitaria, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
Bari, Italy
IRCCS Azienda Ospedaliero-Universitaria di Bologna, UO Pediatria, Programma di Malattie Endocrino-Metaboliche
Bologna, Italy
UOC Endocrinologia e Prevenzione e Cura del Diabete, IRCCS Azienda Ospedaliero-Universitaria di Bologna, Dipartimento di Scienze Mediche e Chirurgiche (DIMEC), Alma Mater Studiorum Università di Bologna
Bologna, Italy
Endocrinologia e Diabetologia, Azienda Ospedaliero-Universitaria di Cagliari, Presidio Ospedaliero Policlinico di Monserrato
Cagliari, Italy
SC Endocrinologia, Diabetologia e Metabolismo, ASO Santa Croce e Carle
Cuneo, Italy
UO Endocrinologia e Malattie del Ricambio, Azienda Ospedaliero Universitaria di Ferrara, Sezione di Endocrinologia, Geriatria e Medicina Interna, Dipartimento di Scienze Mediche, Università degli Studi di Ferrara
Ferrara, Italy
SOD Malattie del Metabolismo Minerale ed Osseo, Azienda Ospedaliero-Universitaria Careggi
Florence, Italy
Clinica Endocrinologica, Dipartimento di Medicina Interna e Specialità Mediche (DiMI), IRCCS Ospedale Policlinico San Martino, Università di Genova
Genova, Italy
UOC di Endocrinologia, AOU Policlinico G. Martino, Dipartimento di Patologia Umana DETEV, Università di Messin
Messina, Italy
Dipartimento di Malattie Endocrino-Metaboliche, IRCCS Istituto Auxologico Italiano
Milan, Italy
Divisione di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini, IEO
Milan, Italy
IRCCS Ospedale San Raffaele
Milan, Italy
SC Endocrinologia, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Italy
Dipartimento di Medicina Clinica e Chirurgia; Unità di Endocrinologia, Diabetologia e Andrologia; Università degli Studi di Napoli Federico II
Naples, Italy
Dipartimento di Pediatria, Azienda Universitaria Ospedaliera della Seconda Università degli Studi di Napoli
Naples, Italy
UOC di Endocrinologia e Malattie del Metabolismo, AOU Università degli Studi della Campania Luigi Vanvitelli
Naples, Italy
SCDU Endocrinologia Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara
Novara, Italy
Unità di Chirurgia Endocrina, Dipartimento di Chirurgia, Oncologia e Gastroenterologia, Università di Padova
Padova, Italy
UOC Endocrinologia, DIMED, Azienda Ospedaliero-Universitaria di Padova
Padova, Italy
UOSD Tumori Ereditari, Endocrinologia Oncologica, Dipartimento Oncologia, Unità Tumori Ereditari, Istituto Oncologico Veneto (IOV) di Padova
Padova, Italy
Unità Operativa Endocrinologia 2, Azienda Ospedaliera Universitaria Pisana
Pisa, Italy
Dipartimento di Medicina Sperimentale, "Sapienza" Università di Roma, Roma - UOC Endocrinologia, Policlinico Umberto I di Roma
Roma, Italy
Unità di Endocrinologia e Andrologia, Dipartimento di Medicina Clinica e Molecolare, AOU Sant'Andrea, Centro di eccellenza ENETS, Università Sapienza di Roma
Roma, Italy
UOC Endocrinologia e Diabetologia, Ospedale Pediatrico Bambin Gesù
Roma, Italy
UOC di Endocrinologia, Diabetologia e Andrologia Medica, IRCCS Humanitas Research Hospital
Rozzano, Italy
Donatello Bone Clinic, Casa di Cura Villa Donatello
Sesto Fiorentino, Italy
Endocrinologia Pediatrica Ospedale Infantile regina Margherita-Dipartimento di Scienze di Sanità Pubblica e Pediatriche, Università degli studi di Torino
Torino, Italy
SCDU Endocrinologia Diabetologia e Malattie del Metabolismo, AOU Città della Salute e della Scienza di Torino, Università di Torino
Torino, Italy
SCDU Endocrinologia Oncologica, AOU Città della Salute e della Scienza di Torino, Università di Torino
Torino, Italy
SOC Endocrinologia, Azienda Sanitaria-Universitaria Friuli Centrale
Udine, Italy
Istituto del Pancreas, Azienda Ospedaliera Universitaria Integrata Verona Policlinico G.B Rossi
Verona, Italy
UOS di Endocrinologia, Policlinico GB Rossi, Azienda Ospedaliera Universitaria Integrata di Verona
Verona, Italy