The International ITP Registry

October 26, 2016 updated by: South Eastern Sydney Local Health District

A Multi-centre, Prospective Disease Registry for Adults Diagnosed With Primary Immune Thrombocytopenia (ITP) in International Countries

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.

Study Overview

Status

Unknown

Conditions

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.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • Australian Capital Territory
      • Canberra, Australian Capital Territory, Australia
        • Recruiting
        • Canberra Hospital
        • Contact:
          • Philip Crispin
    • New South Wales
      • Sydney, New South Wales, Australia
        • Recruiting
        • Prince of Wales Hospital
        • Contact:
          • Tim Brighton
      • Sydney, New South Wales, Australia, 2217
        • Recruiting
        • St George Hospital
        • Contact:
          • Beng H Chong
          • Phone Number: +612 9113 3246
        • Contact:
          • Sarah Davidson
          • Phone Number: +612 9113 2446
        • Principal Investigator:
          • Beng H Chong
      • Sydney, New South Wales, Australia
        • Recruiting
        • Liverpool Hospital
        • Contact:
          • Michael Harvey
      • Sydney, New South Wales, Australia
        • Recruiting
        • Calvary Mater Newcastle
        • Contact:
          • Michelle Gambrill
      • Sydney, New South Wales, Australia
        • Recruiting
        • Concord Hospital
        • Contact:
          • Ilona Cunningham
    • South Australia
      • Adelaide, South Australia, Australia
        • Recruiting
        • Royal Adelaide Hospital
        • Contact:
          • Simon McRae
      • Adelaide, South Australia, Australia
        • Recruiting
        • Flinders Medical Centre
        • Contact:
          • Douglas Coghlan
    • Victoria
      • Melbourne, Victoria, Australia
        • Recruiting
        • St Vincent's Hospital
        • Contact:
          • Hang Quach
      • Melbourne, Victoria, Australia
        • Recruiting
        • The Alfred
        • Contact:
          • Huyen Tran
  • Colombia
      • Busaramanga, Colombia
        • Recruiting
        • FOSCAL
        • Contact:
          • Luis SALAZAR
      • Colombia, Colombia
        • Recruiting
        • Hemato-Oncologos
        • Contact:
          • Rigoberto GOMEZ
      • Colombia, Colombia
        • Recruiting
        • Hospital Pablo Tobón Uribe
        • Contact:
          • Kenny Galvez
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Ji-hyeon KWON
      • Seoul, Korea, Republic of
        • Recruiting
        • Severance Hospital
        • Contact:
          • Jin Seok KIM
      • Seoul, Korea, Republic of
        • Recruiting
        • Asan Medical Centre
        • Contact:
          • Je-Hwan LEE
      • Seoul, Korea, Republic of
        • Recruiting
        • Seoul St Mary's Hospital
        • Contact:
          • Jong Wook LEE
      • Seoul, Korea, Republic of
        • Recruiting
        • Samsung Medical Centre
        • Contact:
          • Jun Ho JANG
  • Kuwait
      • Kuwait City, Kuwait
        • Completed
        • Mubarak Alkabeer Hospital
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Active, not recruiting
        • Ampang Hospital
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Subang Jaya Medical Centre
        • Contact:
          • Soo Chin NG
      • Penang, Malaysia
        • Active, not recruiting
        • Penang Hospital
  • Singapore
      • Singapore, Singapore
        • Recruiting
        • National University Hospital
        • Contact:
          • Dr Liu
      • Singapore, Singapore
        • Recruiting
        • Singapore General Hospital
        • Contact:
          • Lai Heng LEE
  • Taiwan
      • TAiwan, Taiwan
        • Recruiting
        • China Medical University Hospital
        • Contact:
          • Li Yaun BAI
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veteran's General Hospital
        • Contact:
          • Tzeon-Jye Chiou
      • Taiwan, Taiwan
        • Recruiting
        • Mackay Memorial Hospital
        • Contact:
          • Yi-Fang CHANG
      • Taiwan, Taiwan
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
          • Tsai-Yun CHEN
      • Taiwean, Taiwan
        • Recruiting
        • Taichung Veteran's General Hospital
        • Contact:
          • Wen Li HWANG
  • Thailand
      • Bangkok, Thailand
        • Recruiting
        • Siriraj Hospital
        • Contact:
          • Yinyong CHINTHAMMITR
      • Bangkok, Thailand
        • Recruiting
        • Ramathibodi Hospital
        • Contact:
          • Pantep ANGCHAISUKSIRI
      • Chiang Mai, Thailand
        • Recruiting
        • Chiang Mai University
        • Contact:
          • Weerasak NAWARAWONG
      • Thailand, Thailand
        • Recruiting
        • Chulalongkorn University
        • Contact:
          • Pollapat ROJNUCKARIN
      • Thailand, Thailand
        • Recruiting
        • Pramongkutlao College of MEdicine
        • Contact:
          • Tontanai NUMBENJAPON
  • Turkey
      • Ankara, Turkey
        • Recruiting
        • Ankara University
        • Contact:
          • Osman Ilhan
      • Ankara, Turkey
        • Recruiting
        • Ankara Numune Training and Research Hosptial
        • Contact:
          • Funda CERAN
      • Ankara, Turkey
        • Recruiting
        • Ankara Oncology Training and Research Hospital
        • Contact:
          • Fevzi Altuntas
      • PAmukkale, Turkey
        • Recruiting
        • Pamukkale University Medical Faculty
        • Contact:
          • Hakan Ismail SARI
      • Turkey, Turkey
        • Recruiting
        • Dokuz Eylul University Medical Faculty
        • Contact:
          • Mehmet Ali OZCAN
      • Turkey, Turkey
        • Recruiting
        • Erciyes University Medical Faculty
        • Contact:
          • Ali UNAL
      • Turkey, Turkey
        • Recruiting
        • Gaziantep University Medical Faculty
        • Contact:
          • Vahap OKAN
  • Uruguay
      • Uruguay, Uruguay
        • Recruiting
        • CASMU
        • Contact:
          • Lina Foren
      • Uruguay, Uruguay
        • Recruiting
        • Hospital Britanico
        • Contact:
          • Silvia Pierri
      • Uruguay, Uruguay
        • Recruiting
        • Hospital Militar
        • Contact:
          • Maria Virginia COSTA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Primary Immune Thrombocytopaenia
Recently-diagnosed (i.e. < 6 months) primary ITP adult patients (≥ 18 years) characterized by platelet counts less than 100x109/L as defined by the International Working Group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease progression of ITP
Time Frame: up to 24 months
This will include response assessment to each treatment modality, incidence and characteristics of bleeding events, bone marrow results (if available), development of refractory ITP and effects of any medical intervention (whether beneficial or detrimental) in the overall severity of the disease, according to definitions described by the ITP International Working Group.
up to 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

South Eastern Sydney Local Health District

Collaborators

GlaxoSmithKline

Investigators

  • Study Chair: Beng H Chong, SESLHD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

December 1, 2016

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

September 19, 2013

First Submitted That Met QC Criteria

October 22, 2013

First Posted (Estimate)

October 28, 2013

Study Record Updates

Last Update Posted (Estimate)

October 27, 2016

Last Update Submitted That Met QC Criteria

October 26, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CTBR-017 (TRA114972)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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