Improving diagnosis for rare diseases: the experience of the Italian undiagnosed Rare diseases network.


Journal

Italian journal of pediatrics
ISSN: 1824-7288
Titre abrégé: Ital J Pediatr
Pays: England
ID NLM: 101510759

Informations de publication

Date de publication:
14 Sep 2020
Historique:
received: 14 01 2020
accepted: 17 08 2020
entrez: 15 9 2020
pubmed: 16 9 2020
medline: 26 8 2021
Statut: epublish

Résumé

For a number of persons with rare diseases (RDs) a definite diagnosis remains undiscovered with relevant physical, psychological and social consequences. Undiagnosed RDs (URDs) require other than specialised clinical centres, outstanding molecular investigations, common protocols and dedicated actions at national and international levels; thus, many "Undiagnosed RDs programs" have been gradually developed on the grounds of a well-structured multidisciplinary approach. The Italian Undiagnosed Rare Diseases Network (IURDN) was established in 2016 to improve the level of diagnosis of persons with URD living in Italy. Six Italian Centres of Expertise represented the network. The National Centre for Rare Diseases at the Istituto Superiore di Sanità coordinates the whole project. The software PhenoTips was used to collect the information of the clinical cases. One hundred and ten cases were analysed between March 2016 and June 2019. The age of onset of the diseases ranged from prenatal age to 51 years. Conditions were predominantly sporadic; almost all patients had multiple organs involvements. A total of 13/71 family cases were characterized by WES; in some families more than one individual was affected, so leading to 20/71 individuals investigated. Disease causing variants were identified in two cases and were associated to previously undescribed phenotypes. In 5 cases, new candidate genes were identified, although confirmatory tests are pending. In three families, investigations were not completed due to the scarce compliance of members and molecular investigations were temporary suspended. Finally, three cases (one familial) remain still unsolved. Twelve undiagnosed clinical cases were then selected to be shared at International level through PhenomeCentral in accordance to the UDNI statement. Our results showed a molecular diagnostic yield of 53,8%; this value is comparable to the diagnostic rates reported in other international studies. Cases collected were also pooled with those collected by UDNI International Network. This represents a unique example of global initiative aimed at sharing and validating knowledge and experience in this field. IURDN is a multidisciplinary and useful initiative linking National and International efforts aimed at making timely and appropriate diagnoses in RD patients who still do not have a confirmed diagnosis even after a long time.

Sections du résumé

BACKGROUND BACKGROUND
For a number of persons with rare diseases (RDs) a definite diagnosis remains undiscovered with relevant physical, psychological and social consequences. Undiagnosed RDs (URDs) require other than specialised clinical centres, outstanding molecular investigations, common protocols and dedicated actions at national and international levels; thus, many "Undiagnosed RDs programs" have been gradually developed on the grounds of a well-structured multidisciplinary approach.
METHODS METHODS
The Italian Undiagnosed Rare Diseases Network (IURDN) was established in 2016 to improve the level of diagnosis of persons with URD living in Italy. Six Italian Centres of Expertise represented the network. The National Centre for Rare Diseases at the Istituto Superiore di Sanità coordinates the whole project. The software PhenoTips was used to collect the information of the clinical cases.
RESULTS RESULTS
One hundred and ten cases were analysed between March 2016 and June 2019. The age of onset of the diseases ranged from prenatal age to 51 years. Conditions were predominantly sporadic; almost all patients had multiple organs involvements. A total of 13/71 family cases were characterized by WES; in some families more than one individual was affected, so leading to 20/71 individuals investigated. Disease causing variants were identified in two cases and were associated to previously undescribed phenotypes. In 5 cases, new candidate genes were identified, although confirmatory tests are pending. In three families, investigations were not completed due to the scarce compliance of members and molecular investigations were temporary suspended. Finally, three cases (one familial) remain still unsolved. Twelve undiagnosed clinical cases were then selected to be shared at International level through PhenomeCentral in accordance to the UDNI statement.
CONCLUSIONS CONCLUSIONS
Our results showed a molecular diagnostic yield of 53,8%; this value is comparable to the diagnostic rates reported in other international studies. Cases collected were also pooled with those collected by UDNI International Network. This represents a unique example of global initiative aimed at sharing and validating knowledge and experience in this field. IURDN is a multidisciplinary and useful initiative linking National and International efforts aimed at making timely and appropriate diagnoses in RD patients who still do not have a confirmed diagnosis even after a long time.

Identifiants

pubmed: 32928283
doi: 10.1186/s13052-020-00883-8
pii: 10.1186/s13052-020-00883-8
pmc: PMC7488856
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

130

Subventions

Organisme : Ministero degli Affari Esteri e della Cooperazione Internazionale
ID : PGR00229, 2016-19

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Auteurs

Marco Salvatore (M)

National Centre for Rare Diseases, Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, Rome, Italy. marco.salvatore@iss.it.

Agata Polizzi (A)

Department of Educational Science, University of Catania, Catania, Italy.

Maria Chiara De Stefano (MC)

National Transplantation Centre, Istituto Superiore di Sanità, Rome, Italy.

Giovanna Floridia (G)

Bioethics Unit, Istituto Superiore di Sanità, Rome, Italy.

Simone Baldovino (S)

Department of Clinical and Biological Sciences, University of Turin and S. Giovanni Bosco Hospital, Centre of Research of Immunopathology and Rare Diseases - Regional Coordinating Centre of the National Network for Rare Diseases, Turin, Italy.

Dario Roccatello (D)

Department of Clinical and Biological Sciences, University of Turin and S. Giovanni Bosco Hospital, Centre of Research of Immunopathology and Rare Diseases - Regional Coordinating Centre of the National Network for Rare Diseases, Turin, Italy.

Savino Sciascia (S)

Department of Clinical and Biological Sciences, University of Turin and S. Giovanni Bosco Hospital, Centre of Research of Immunopathology and Rare Diseases - Regional Coordinating Centre of the National Network for Rare Diseases, Turin, Italy.

Elisa Menegatti (E)

Department of Clinical and Biological Sciences, University of Turin and S. Giovanni Bosco Hospital, Centre of Research of Immunopathology and Rare Diseases - Regional Coordinating Centre of the National Network for Rare Diseases, Turin, Italy.

Giuseppe Remuzzi (G)

IRCCS Mario Negri Pharmacological Research Institute, Regional Coordinating Centre of the National Network for Rare Diseases, Clinical Research Centre for Rare Diseases "Aldo e Cele Daccò", Ranica, Bergamo, Italy.

Erica Daina (E)

IRCCS Mario Negri Pharmacological Research Institute, Regional Coordinating Centre of the National Network for Rare Diseases, Clinical Research Centre for Rare Diseases "Aldo e Cele Daccò", Ranica, Bergamo, Italy.

Paraskevas Iatropoulos (P)

IRCCS Mario Negri Pharmacological Research Institute, Regional Coordinating Centre of the National Network for Rare Diseases, Clinical Research Centre for Rare Diseases "Aldo e Cele Daccò", Ranica, Bergamo, Italy.

Bruno Bembi (B)

S.O.C. Regional Coordinating Centre of the National Network for Rare Diseases, S. Maria della Misericordia Hospital, Udine, Italy.

Rosalia Maria Da Riol (RM)

S.O.C. Regional Coordinating Centre of the National Network for Rare Diseases, S. Maria della Misericordia Hospital, Udine, Italy.

Alessandra Ferlini (A)

Department of Experimental and Diagnostic Medicine, University of Ferrara, Ferrara, Italy.

Marcella Neri (M)

Department of Experimental and Diagnostic Medicine, University of Ferrara, Ferrara, Italy.

Giuseppe Novelli (G)

Department of Biomedicine and Prevention, University of Tor Vergata and University Hospital Tor Vergata, Unit of Medical Genetics Rome & IRCCS Neuromed, Pozzilli, Italy.

Federica Sangiuolo (F)

Department of Biomedicine and Prevention, University of Tor Vergata and University Hospital Tor Vergata, Unit of Medical Genetics, Rome, Italy.

Francesco Brancati (F)

Department of Life, Health and Environmental Sciences, Unit of Medical Genetics University of L'Aquila, L'Aquila, Italy.

Domenica Taruscio (D)

National Centre for Rare Diseases, Undiagnosed Rare Diseases Interdepartmental Unit, Istituto Superiore di Sanità, Rome, Italy.

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