Study to to evaluate the occurrence of Myeloproliferative neoplasm (a type of disease in which the bone marrow makes too many RBC, platelets, or certain WBC) & to characterize treatment patterns & burden/ symptoms of illness under routine medical practice
- Conditions
- Health Condition 1: null- Myeloproliferative neoplasms
- Registration Number
- CTRI/2014/05/004598
- Lead Sponsor
- ovartis Healthcare Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 0
1. Male or female patients >= 18 years of age who have been diagnosed with a Ph-MPN
according to the 2008 revised World Health Organization criteria
2.Willing and able to provide written informed consent according to local guidelines prior to
any study procedures
3. Have availability of historical medical records that verify diagnosis
4. Willing to complete and literate in the language of the available health related quality of
life (HRQoL) instrument either alone or with minimal assistance from caregivers and/or
trained site personnel
1. According to the investigatorâ??s opinion, the patient is an unlikely candidate to obtain longterm
follow-up information for any reasons such as unavailability or severe concomitant
illnesses
2. Patients with active alcohol or drug addiction that would interfere with their ability to
comply with the study requirements
3. Patients with any concurrent condition that, in the Investigatorâ??s opinion, would
jeopardize the safety of the patient or compliance with the protocol
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To describe the current diagnosis, treatment, pattern <br/ ><br>in ET, PV, and MF patients in routine clinical practiceTimepoint: Diagnosis, Treatment patterns (incidence, prevalence, <br/ ><br>drug therapy used, duration, reason for <br/ ><br>discontinuation, treatment dose adjustment) <br/ ><br>Sequencing/changes in therapies <br/ ><br>Reason/s to change treatment (including dose <br/ ><br>changes) <br/ ><br>Time to disease progression from baseline
- Secondary Outcome Measures
Name Time Method To assess the economic burden captured by medical <br/ ><br>resource utilizations using common reference units <br/ ><br>(e.g., number of hospital admissions and days in <br/ ><br>hospital)Timepoint: Change in frequency of resource utilization from <br/ ><br>baseline <br/ ><br>Change in frequency of resource utilization from <br/ ><br>current line of therapy to subsequent line of therapy;To describe patient QOL and the association of QOL <br/ ><br>with change of therapyTimepoint: QOL <br/ ><br>Change in QOL from baseline to change in therapy <br/ ><br>Change in QOL from current line of therapy to <br/ ><br>subsequent line of therapy