Investigation on a Dynamic Cohort of Italian Patients With Active ITP
NCT ID: NCT03465020
Last Updated: 2022-07-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
861 participants
OBSERVATIONAL
2018-10-15
2023-07-31
Brief Summary
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Detailed Description
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Previously, 'acute ITP' was used to describe a self-limited form of the disease and 'chronic ITP' to describe the disease if it lasted for more than 6 months. In 2009, a new terminology for ITP was agreed upon based on the duration of the disease. The new terms for ITP are: 'newly diagnosed ITP (from diagnosis to 3 months), 'persistent ITP' (3-12 months) and 'chronic ITP' (lasting for more than 12 months) \[2\].
Chronic primary ITP in adults is slightly more common in women of childbearing age but the sex incidence is similar in patients over 60. The incidence of ITP in adults is around 4 per 100.000 people per year, with a UK prevalence of up to 24 per 100.000 people \[4-6\]. No more than 2 per 100.000 will require ITP treatment.
Bleeding is highly variable and there is great heterogeneity. Bleeding is most commonly mucocutaneous, involving the skin and subcutaneous tissue (petechiae, ecchymoses, subcutaneous hematomas), the external mucosae (epistaxis, gum bleeding, blood blisters in the mouth), muscles (muscle hematomata) or the various organs and internal mucosae (hematuria, gastrointestinal bleeding, menorrhagia, intracerebral bleeding). Major bleeding is not common if the platelet count is above 30x109/L. Intracranial hemorrhage is rare and is most often seen in older patients who have additional comorbidities and in patients who fail to respond to therapy. The yearly risk of fatal hemorrhage is around 1.6-3.9% in unresponsive patients. This risk varies with age, from 0.4% per year in patients below 40 years old to 13% per year in those over 60. The natural history of ITP with currently available treatments is not well known. Available data are mostly based on the era when rituximab and thrombopoietin-receptor agonists (TPO-RA) were not in use.
There is a lack reliable data on how recent treatments have modified the course of the disease. Bleeding frequency and severity, complications like infections, thrombosis, ITP-related symptoms like fatigue, etc. are also largely unknown as are women's related issues. Similarly, the cost of treatment for a patient with ITP is not available. Safety and efficacy of specific recent treatments have been measured mostly in industry-sponsored studies. Furthermore, most studies did not conform to the International Working Group (IWG) on ITP recommendations concerning terminology, definitions, outcome criteria and assessment of bleeding.
To the investigator's knowledge, an ITP Registry is ongoing in UK and in Australia and registries are being planned in other European countries with a prospective of creating an international network. The only established international registry, the ITP PARC study, is operative since 2004 but covers different aspects of the disease. The few Italian registries are of regional dimension and are not aligned to collect standardized information in a uniform way.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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ITP patients
On active treatment
Observation
Safety and efficacy outcomes of patients on different treatments
Interventions
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Observation
Safety and efficacy outcomes of patients on different treatments
Eligibility Criteria
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Inclusion Criteria
* Patients already treated for whom a new line of ITP treatment is initiated by the recruiting center (the patients could have been treated elsewhere before)
* Patients who, under any ITP treatment at the recruiting center.
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Fondazione Progetto Ematologia
OTHER
Gruppo Italiano Malattie EMatologiche dell'Adulto
OTHER
Responsible Party
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Principal Investigators
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Francesco Rodeghiero
Role: STUDY_CHAIR
Department of Hematology, S. Bortolo Hospital of Vicenza
Marco Ruggeri
Role: STUDY_DIRECTOR
Department of Hematology, S. Bortolo Hospital, Vicenza
Locations
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Sc Ematologia E Centro Trapianti Midollo Osseo
Parma, SC, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, , Italy
Aou Consorziale Policlinico - Bari - Uo Ematologia Con Trapianto
Bari, , Italy
Aou Di Bologna - Policlinico S. Orsola-Malpighi - Uoc Ematologia
Bologna, , Italy
Ao Brotzu, Presidio Ospedaliero A. Businco - Cagliari - Sc Ematologia E Ctmo
Cagliari, , Italy
Ctc U.O Di Ematologia Con Trapianto Di Midollo Osseo - Catania
Capranica, , Italy
Arnas Garibaldi, Po Garibaldi-Nesima - Catania - Uoc Ematologia
Catania, , Italy
Aou Careggi - Firenze - Sod Ematologia
Florence, , Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, , Italy
Fondazione Irccs Ca' Granda, Ospedale Maggiore Policlinico - Milano - Ematologia - Padiglione Marcora
Milan, , Italy
Asst Di Monza, Ospedale S. Eugenio - Uo Ematologia E Cta
Monza, , Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Napoli, , Italy
Aou Federico Ii - Napoli - Uoc Ematologia
Napoli, , Italy
Aou Maggiore Della Carita' Di Novara - Scdu Ematologia
Novara, , Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo, , Italy
Ospedale S.M. della Misericordia - STROKE UNIT
Perugia, , Italy
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, , Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, , Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, , Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, , Italy
Asl Taranto, Ospedale Ss. Annunziata - Uoc Ematologia
Taranto, , Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia - Università Degli Studi Di Torino
Torino, , Italy
Ente Ecclesiastico Cardinale G. Panico - Tricase - Uo Ematologia
Tricase, , Italy
Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia
Trieste, , Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, , Italy
Aulss 8 Berica - Ospedale Di Vicenza - Uoc Ematologia
Vicenza, , Italy
Countries
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Central Contacts
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Facility Contacts
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Crugnola
Role: primary
Gresele
Role: primary
Marco Ruggeri
Role: primary
Other Identifiers
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ITP0918
Identifier Type: -
Identifier Source: org_study_id
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