Clinical trial NCT01970189: The International ITP Registry
Official title: A Multi-centre, Prospective Disease Registry for Adults Diagnosed With Primary Immune Thrombocytopenia (ITP) in International Countries
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thrombocytopenia
Keywords: Immune Thrombocytopenia
Primary Immune Thrombocytopenia
Purpura, Thrombocytopenic, Idiopathic
Autoimmune Thrombocytopenia
Thrombocytopenia
Lead sponsor: South Eastern Sydney Local Health District
Sponsor class: OTHER_GOV
Collaborators: name: GlaxoSmithKline
First posted: 2013-10-28
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults recently-diagnosed with primary ITP will be prospectively enrolled into the registry. In cases where prospective data collection is not possible from initial diagnosis, eg if sites see mainly referred patients, those patients with pre-existing ITP of no longer than 6 months duration since diagnosis will be allowed into the registry, provided they are still prospectively being followed up or under ongoing review / treatment at the participating institution.

Brief summary: Primary immune thrombocytopenia (ITP) is an uncommon disease characterised by a low platelet count, which may cause the patient to have a higher risk or increased duration of bleeding. Individual hospitals only encounter a small number of ITP patients each year which makes it difficult to study this disease. By creating this disease registry, we will be able to build a more complete picture of ITP, including treatment practices, through collecting information about the condition from patients across several hospitals in several countries. Research of this kind will help future patients by providing doctors with information about ITP, and about how patients have been treated.

Detailed description: This is an observational disease registry database for recently-diagnosed adult patients with primary ITP that aims to understand the natural history of this rare disease and disease management. Participating investigators will prospectively enter real-world patient data on their enrolled patients with a minimum of 2 years follow up.

Data from this registry will be used to generate descriptive statistics on demographics, clinical characteristics including prevalence and incidence of co-morbidities, treatment patterns, and adverse outcomes (resulting from treatment or disease) on ITP patients on an annual basis. The information will be generated at the national or combined-country level. Furthermore, each institution will have an access to its data and may choose to generate descriptive statistics for its specific institution on a more frequent, ad-hoc basis. New research questions or questions addressing a subset of registry patients to take advantage of combined registry data will require a separate protocol and review by independent committees

The focus of this protocol is on adults with primary ITP, however, in future there may be interest to expand the population to explore secondary ITP patients as well. Hence, this registry is built to allow for some optional preliminary information related to secondary ITP to be captured.

Multi-site participation of this registry project will be rolled out in stages, and will be offered to centres with appropriate expertise. Pilot countries included Australia, Korea, Taiwan, Singapore, Malaysia, Japan, Thailand and Turkey and sites will be selected based on their potential research (interest, resources, and expected patient volume). Additional sites may be added in the future from countries in Asia Pacific, Middle East and Latin America. Japan has an independent national ITP registry run by the government, however voluntary participation of interested Japanese investigators in this database will be welcomed, therefore allowing comparison of data between Japanese and non-Japanese patients.

Eligibility criteria: Inclusion Criteria:

1. Recently-diagnosed (i.e. \< 6 months) primary ITP adults patients (≥ 18 years) characterized by platelet counts less than 100x109/L as defined by the International Working Group1.
2. Able to provide written consent for data to be included in the registry

Primary outcomes:
measure: Disease progression of ITP
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Canberra
country: Australia
facility: Canberra Hospital
state: Australian Capital Territory
city: Sydney
country: Australia
facility: St George Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Calvary Mater Newcastle
state: New South Wales
city: Sydney
country: Australia
facility: Concord Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: Sydney
country: Australia
facility: Prince of Wales Hospital
state: New South Wales
city: Adelaide
country: Australia
facility: Flinders Medical Centre
state: South Australia
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Melbourne
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Melbourne
country: Australia
facility: The Alfred
state: Victoria
city: Busaramanga
country: Colombia
facility: Foscal
city: Colombia
country: Colombia
facility: Hemato-Oncologos
city: Colombia
country: Colombia
facility: Hospital Pablo Tobón Uribe
city: Seoul
country: Korea, Republic of
facility: ASAN Medical Centre
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Centre
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul St Mary's Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
city: Kuwait City
country: Kuwait
facility: Mubarak Alkabeer Hospital
city: Kuala Lumpur
country: Malaysia
facility: Ampang Hospital
city: Kuala Lumpur
country: Malaysia
facility: Subang Jaya Medical Centre
city: Penang
country: Malaysia
facility: Penang Hospital
city: Singapore
country: Singapore
facility: National University Hospital
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Taipei
country: Taiwan
facility: Taipei Veteran's General Hospital
city: TAiwan
country: Taiwan
facility: China Medical University Hospital
city: Taiwan
country: Taiwan
facility: Mackay Memorial Hospital
city: Taiwan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taiwean
country: Taiwan
facility: Taichung Veteran's General Hospital
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
city: Chiang Mai
country: Thailand
facility: Chiang Mai University
city: Thailand
country: Thailand
facility: Chulalongkorn University
city: Thailand
country: Thailand
facility: Pramongkutlao College of MEdicine
city: Ankara
country: Turkey
facility: Ankara Numune Training and Research Hosptial
city: Ankara
country: Turkey
facility: Ankara Oncology Training and Research Hospital
city: Ankara
country: Turkey
facility: Ankara University
city: PAmukkale
country: Turkey
facility: Pamukkale University Medical Faculty
city: Turkey
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Turkey
country: Turkey
facility: Erciyes University Medical Faculty
city: Turkey
country: Turkey
facility: Gaziantep University Medical Faculty
city: Uruguay
country: Uruguay
facility: CASMU
city: Uruguay
country: Uruguay
facility: Hospital Britanico
city: Uruguay
country: Uruguay
facility: Hospital Militar
Study officials:
affiliation: SESLHD
name: Beng H Chong
role: STUDY_CHAIR
References: