RecruitingNCT06645951

Institution of an Italian Multicenter Database of Patients with Parathyroid Carcinoma or Atypical Parathyroid Adenoma

Creation, Management and Analysis of a National Database of Patients with Parathyroid Carcinoma or Atypical Parathyroid Adenoma


Sponsor

F.I.R.M.O. - Fondazione Italiana Ricerca sulle Malattie dell'Osso - Ente del Terzo Settore

Enrollment

300 participants

Start Date

Nov 4, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The goal of this observational study is to create, manage and analyze a multicenter national database of patients with parathyroid carcinoma or atypical parathyroid adenoma, aimed at collecting and studying anamnestic, diagnostic, genetic, clinical, histological, and therapeutic data in a relatively wide number of patients in Italy. The study will include 33 specialist clinical centers of endocrinology 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 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 progression at the recruiting clinical centers. Collected data will include both the most classic traits of the pathology and the less common ones, with the final goal of refining and deepening medical knowledge in the field of these two extremely rare parathyroid cancers and be able to define optimal clinical and therapeutic management of patients, improving their quality and life expectancy. The main aspects this observational study aims to assess and clarify are: 1. Evaluation of prevalence and incidence of parathyroid carcinoma and atypical parathyroid adenoma in Italy, both as sporadic disease or in the context of genetic disorders. 2. Clinical, histological, and biochemical characterization of parathyroid carcinoma vs atypical parathyroid adenoma, to assess features and aspects that distinguish these two kinds of tumors and may help in the differential diagnosis. 3. Evaluation of short-term and long-term response to therapies in patients with parathyroid carcinoma and in patients with atypical parathyroid adenoma to assess possible differences between these two types of cancer and, thus, to design tailored clinical and therapeutic managements for patients. 4. Evaluation of short-term and long-term response to therapies in sporadic forms vs genetic forms of parathyroid carcinoma and atypical parathyroid adenoma, to assess possible differences between these two different forms of diseases and, thus, to design tailored clinical and therapeutic managements for patients. The study will include two independent cohorts of female and male patients of any age, one including patients who developed parathyroid carcinoma (cohort 1) and one including patients who developed atypical parathyroid adenoma (cohort 2), both as sporadic cancer or in the context of genetic diseases. 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. Treatments (surgery and/or drugs), for which data on response to therapy will be collected in the database, are those that are conventionally used in patients with parathyroid carcinoma or atypical parathyroid adenoma for treatment of their pathology, regardless of their inclusion in this observational study.


Eligibility

Inclusion Criteria2

  • Cohort 1: parathyroid carcinoma
  • Cohort 2: atypical parathyroid adenoma

Exclusion Criteria1

  • None

Locations(33)

U.O.C. Endocrinologia, Azienda Ospedaliero Universitaria Policlinico Consorziale, Università degli Studi di Bari "Aldo Moro"

Bari, 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

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

Unità di Chirurgia Endocrina, Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

Ospedale Casa Sollievo della Sofferenza

Foggia, Italy

Clinica Endocrinologica, Dipartimento di Medicina Interna e Specialità Mediche (DiMI), IRCCS Ospedale Policlinico San Martino, Università di Genova

Genova, Italy

Clinica Pediatrica ed Endocrinologia, IRCCS Ospedale Pediatrico Giannina Gaslini

Genova, Italy

U.O.S.D. Centro Malattie Rare · Dipartimento di Pediatria IRCCS Ospedale Pediatrico Giannina Gaslini

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

Endocrinologia Infantile, UOU di Pediatria, IRCCS Ospedale San Raffaele

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

Napoli, Italy

UOC di Endocrinologia e Malattie del Metabolismo, AOU Università degli Studi della Campania Luigi Vanvitelli

Napoli, Italy

SCDU Endocrinologia Azienda Ospedaliero-Universitaria Maggiore della Carità di Novara

Novara, Italy

Endocrinologia, Clinica Polispecialistica San Carlo

Paderno Dugnano, Italy

Unità di Chirurgia Endocrina, Dipartimento di Chirurgia, Oncologia e Gastroenterologia, Università di Padova

Padua, Italy

UOC Endocrinologia, DIMED, Azienda Ospedaliero-Universitaria di Padova

Padua, 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 Patologie osteo-metaboliche e della tiroide, Fondazione Policlinico universitario Campus Bio-Medico

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

Dipartimento di Scienze Mediche, Chirurgiche e Neuroscienze, Policlinico Santa Maria delle Scotte, Università di Siena

Siena, 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

IRCCS Materno-Infantile Burlo Garofolo

Trieste, Italy

SOC Endocrinologia, Azienda Sanitaria-Universitaria Friuli Centrale

Udine, Italy

UOS di Endocrinologia, Policlinico GB Rossi, Azienda Ospedaliera Universitaria Integrata di Verona

Verona, Italy

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