Undiagnosed Rare Diseases: a bilateral project between. Italy (Istituto Superiore di Sanità) and USA (NIH)
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1 Undiagnosed Rare Diseases: a bilateral project between Italy (Istituto Superiore di Sanità) and USA (NIH) Domenica Taruscio & Marco Salvatore National Centre for Rare Diseases Istituto Superiore di Sanità, Rome Italy
2 The Undiagnosed Diseases Network International: The first meeting International Conference September 2014, Roma
3 First International Conference ISS, Sept, 2014 Rome 2015 Board members: G. Baynam (Australia), H. Cederroth (Sweden), W. Gahl (USA), S. Groft (USA), K. Kosaki (Japan), P. Lasko (Canada), B. Melegh (Hungary), D Taruscio (Italy)
4 AIMS of UDNI: ü ü ü ü Improve the level of diagnosis and care for patients with UND through the development of common protocols designed by a large community of investigators. Facilitate research into the etiology of undiagnosed diseases, by collecting and sharing standardized, high-quality clinical and laboratory data, including genotyping, phenotyping, and documentation of environmental exposures. Create an integrated and collaborative community across multiple Countries and among laboratory and clinical investigators prepared to investigate the pathophysiology ofthese newlyrecognized and rare diseases. TO SHARE: Best practices, protocols, consents, phenotypes, genomic data, functional analyses and models, knowledge management tools
5 UDNI Website (management by CNMR, Istituto Superiore di Sanità ) ü UDNI Information (background, principles, practices, membership application form) ü Dissemination of UDNI activities ü UDNI Programs of participating Countries ü NEWSLETTER
6 Membership List, ordered alphabetically by Country name Australia Austria Belgium Canada France Germany Hungary Israel India Italy Japan Korea Spain Sri Lanka Sweden Turkey, Cina: starting! Thailand The Netherlands United States
7 UDNI Update: Membership Ø In GREEN: Countries with at least one UDN Program Ø Membership requests are increasing
8 Membership: Clinical investigatorsserving undiagnosed disease fromallcountries. New proposal (Stockholm Conference; to be agreed on June conference) Clinical, Non-Clinical, Institutional, Patient Advocacy/Engagement
9 Past Conferences I International Conference on Rare and Undiagnosed Diseases September 2014, Rome II International Conference on Rare and Undiagnosed Diseases June 2015, Budapest III International Conference on Rare and Undiagnosed Diseases 18 February 2016, Wien IV International Conference on Rare and Undiagnosed Diseases November 2016, Tokyo
10 Past Conference V International Conference on Rare and Undiagnosed Diseases August 2017, Stockholm - Sweden
11 V International Conference on Rare and Undiagnosed Diseases August 2017, Stockholm - Sweden
12 VI International Conference, June 2018, Naples (Italy)
13
14 UDN Program Italy Undiagnosed Rare Diseases: a joint Italy USA project Bilateral Project: Italy- USA Short ID card Funded by the Italian Ministry of Foreign Affairs and International Collaborations ( ) Coordinated by National Center Rare Diseases, Istituto Superiore di Sanità, Italy (Dr. D. Taruscio) 6 Clinical Italian Centres: Turin, Bergamo, Udine, Ferrara, L Aquila, Rome USA Partner: National Human GenomeResearch Institute, NIH (Dr. W.A. Gahl)
15 Undiagnosed Rare Diseases: a joint Italy USA project AIMS Ø Ø Ø Ø to collect & characterize patients with undiagnosed diseases, from the Italian Network for Rare Diseases (Italian law 279/2001), sharing common standards and terminologies for URD classification; to establish a National database, interoperable at International level; to perform genetic molecular analysis in selected cases; to strengthen International collaborations to define a diagnosis for patients
16 Undiagnosed Rare Diseases: a joint Italy USA project Pilot phase of the project: 1 Coordinating Centre: Istituto Superiore di Sanità 6 clinical participating centres IRCCS - Istituto di Ricerche Farmacologiche "Mario Negri", Centro di Ricerche Cliniche per le Malattie Rare, Bergamo Dr. E. Daina, Prof G. Remuzzi, Dr P. Iatropoulos, Dr. E. Bresin Centro Multidisciplinare di immunopatologia e documentazione su malattie rare, Torino Prof. D. Roccatello, Dr. S. Baldovino; Dr. S. Sciascia, E. Menegatti Lab. MR Centro Regionale di Coordinamento per le Malattie Rare A.O.U. "Santa Maria della Misericordia" di Udine, Udine Dr. B. Bembi, Dr. R. Dariol U.O. Logistica Genetica Medica, Dip. Scienze Mediche, Università Ferrara, Ferrara Prof. A. Ferlini, Dr. M. Neri Genetica Medica, Università degli Studi de L Aquila, L Aquila Prof. F. Brancati COORDINATION: National Center for Rare Diseases, Istituto Superiore di Sanità, Rome Dr. D. Taruscio, Dr. M. Salvatore, Dr. MC de Stefano, Dr. Federica Censi, Dr. G. Floridia UOC Genetica Medica, Policlinico Tor Vergata, Rome Prof. G. Novelli, Prof F. Sangiuolo, F. Brancati
17 UDN P ITALY Undiagnosed Rare Diseases a joint Italy USA project National Network for Rare diseases (DM 279/2001) 172 Centres UDNI Data collection in the Italian UDN database Italian National Rare Diseases Registry
18 Undiagnosed Rare Diseases: a joint Italy USA project ü Methodologies and criteria for inclusion of clinic cases in the ISS database are shared with the participating centres by: Call Conferences Meetings Workshop (Rome: March 2016, Turin: January 2017; Turin: January 2018) ü Italian UDNP web site: description of the project, participants and expected outcomes
19 Inclusion criteria: NEW! Ø Deep-phenotyping: Patients who remain without a clear clinical diagnosis although extensively and thoroughly investigated; Ø Patient phenotypes must be expressed using Human Phenotype Ontology (HPO) terms in order to ensure comparability with other patients both within and outside of the Network; Ø HPO terms should be defined and shared among participants; Ø Any age: both adult and paediatric patients; Ø No molecular diagnosis: no hypothesized cause-effect relationship over known genotype-phenotype correlation; Ø Any inheritance: Familiar, sporadic cases, ethnic isolates
20 Matchmaker Exchange: Connected Nodes Matchmaker Exchange -project launched in October involves a large number of teams and projects working towards a federated platform (Exchange) - to facilitate the matching of cases with similar phenotypic and genotypic profiles (matchmaking) through standardized application programming interfaces (APIs) and procedural conventions. Philippakis AA et al, The Matchmaker Exchange: A Platform for Rare Disease Gene Discovery. Human Mutation, 36: doi: /humu.22858
21 CASES in the ISS database: 60 (progressively increasing) Selected cases in ISS PhenoTips Database: Ferrara andbergamowillpresentsome ofthe cases includedintothe database 1. Deep sequencing (WES/WGS of family and trios) 2. Contribution of cases to data display and matching framework of PhenomeCentral (UDNI; 10 cases)
22 PhenomeCentral: cases entered by UDN ISS Italy Number of cases entered: 10 Ø Data types submitted (HPO terminology): ü Patient information ü Family history and pedigree ü Prenatal and perinatal history ü Medical history ü Clinical symptoms and physical findings ü List of genes (candidate and/or previously tested, unlikely causative) Each of the cases is shared (fully accessible) with UDNI Work Group on PhenomeCentral
23 Contanct us:
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