Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000805976
Ethics application status
Approved
Date submitted
20/07/2011
Date registered
1/08/2011
Date last updated
8/03/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Study of different treatment strategies for essential thrombocythaemia patients who presented to the Launceston General Hospital, Tasmania, Australia
Scientific title
Study of different treatment strategies for essential thrombocythaemia patients who presented to the Launceston General Hospital
Secondary ID [1] 262666 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Essential thrmbocythaemia 268371 0
Condition category
Condition code
Blood 268505 268505 0 0
Haematological diseases
Cancer 268513 268513 0 0
Thrombocythaemia

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Essential thrombocythaemia (ET) is part of myelproliferative disorders (haematological malignancy) that affect usually adult patients. This disease is characterised by high platelet counts and may associated with either bleeding or clotting. There is no data available currently regarding treatment strategy or response for this cohort of patients in northern Tasmania. This study will target ET patients who are presenting at the Launceston General Hospital for a period of 12 months. Although this haematological cancer is considered relatively uncommon, an increased incidence from 1 to 3 cases/100,000 population per year was observed based on the recent WHO 2008 diagnostic criteria, taking into consideration genetic markers, mainly the JAK2-V617F mutation, in conjunction with a lower threshold of platelet levels (450/nL). ET disease is a treatable chronic disease with at least three different medications that are currently available in Australia. There is no clear records or documentation in Tasmania regarding the response rate and complications of the disease as well as toleration to these different medications. We are assessing for all patinets in the study; the full blood count, genetic abnormalities and record the response to the treatment. This will be conducted via reviewing medical data and laboratory results. The duration of the trial will be 12 months period.
Intervention code [1] 267011 0
Not applicable
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269250 0
To assess platelet counts in patients with essential thrombocythaemia after treatment with different anti-platelets agents e.g. Hydroxyurea, anagerlide and interferon alpha.
Timepoint [1] 269250 0
12 months
Primary outcome [2] 269251 0
To determine the risk factors for essential thrombocythaemia that may influence treatment-response. This will be assessed by molecular studies in addition to full blood counts.
Timepoint [2] 269251 0
12 months
Primary outcome [3] 269252 0
To record any complications of the disease or side effects of the treatment for future references. These complications include bleeding, thrombosis and disease progression.
Timepoint [3] 269252 0
12 months
Secondary outcome [1] 279218 0
To document the treatment modalities or any other related data such as Haemoglobin and WCC profile for these patients.
Timepoint [1] 279218 0
12 months
Secondary outcome [2] 279219 0
To assess the prevalence of essential thrombocythaemia among northern Tasmania patients.
Timepoint [2] 279219 0
12 months

Eligibility
Key inclusion criteria
patients over 18 years of age with essential thrombocythaemia who are presented to Launceston General Hospital during the period of August 2011- August 2012
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients who have transient or reactive thrombocytosis or below age of 18 years.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/08/2011
Actual
1/01/2009
Date of last participant enrolment
Anticipated
Actual
31/12/2012
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
86
Recruitment in Australia
Recruitment state(s)
TAS

Funding & Sponsors
Funding source category [1] 267488 0
Hospital
Name [1] 267488 0
Launceston General Hospital
Country [1] 267488 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Clifford Craig Medical Trust Fund
Address
Level 5
Launceston General Hospital
Charles street
Launceston, Tasmania 7250
Australia
Country
Australia
Secondary sponsor category [1] 266532 0
None
Name [1] 266532 0
Address [1] 266532 0
Country [1] 266532 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269457 0
Tasmanian Human Research Ethics Committee
Ethics committee address [1] 269457 0
University of Tasmania
Private Bag 01
Hobart, Tas 7001
Australia
Ethics committee country [1] 269457 0
Australia
Date submitted for ethics approval [1] 269457 0
01/06/2011
Approval date [1] 269457 0
29/07/2011
Ethics approval number [1] 269457 0
H0011708

Summary
Brief summary
The purpose of this retrospective study was to assess ET patients who were treated with different anti-platelet agents and to elucidate the risk factors, gender prevalence and molecular genetics within different treatment modalities for ET. This study aims to evaluate drug tolerance and response to the treatment with hydroxyurea, anagrelide, IFN a and aspirin (either alone or in combination with the three aforementioned cytoreductive therapies). Furthermore, exploratory analysis of full blood counts (FBC) and JAK2 mutation results of all patients were conducted in order to establish any correlation between these haematological indices, treatment and disease outcomes, with the purpose of aiding clinicians to recognise the best treatment approach and improve the disease outcome by using the most appropriate management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32899 0
Prof Professor Alhossain Khalafallah
Address 32899 0
Launceston General Hospital
Charles Street
TAS 7250
Country 32899 0
Australia
Phone 32899 0
+61367776777
Fax 32899 0
Email 32899 0
[email protected]
Contact person for public queries
Name 16146 0
Prof A/Professor Alhossain A. Khalafallah
Address 16146 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia
Country 16146 0
Australia
Phone 16146 0
+61373487111
Fax 16146 0
+61373487695
Email 16146 0
[email protected]
Contact person for scientific queries
Name 7074 0
Prof A/Professor Alhossain A. Khalafallah
Address 7074 0
Launceston General Hospital
Charles Street, Launceston, TAS 7250
Australia
Country 7074 0
Australia
Phone 7074 0
+61373487111
Fax 7074 0
+61373487695
Email 7074 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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Documents added automatically
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