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

• Register: CTRI
• Last refreshed on: 24 November 2021
• Main ID: CTRI/2014/05/004598
• Date of registration: 15-05-2014
• Prospective Registration: No
• Primary sponsor: Novartis Healthcare Pvt Ltd
• Public title: 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
• Scientific title: Myeloproliferative neoplasms Epidemiological Registry in Growing and Emerging markets - The MERGE Study
• Date of first enrolment: 14-04-2014
• Target sample size: 500
• Recruitment status: Completed
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=8464
• Study type: Observational
• Study design: Other; Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
• Phase: N/A

Countries of recruitment

Algeria, China, Hong Kong, India, Israel, Jordan, Kuwait, Lebanon, Malaysia, Pakistan, Philippines, Qatar, Republic of Korea, Singapore, Taiwan, Turkey, United Arab Emirates, Viet Nam

Contacts

• Name: Dr Manish Mistry
• Affiliation: Novartis India Limited

• Name: Dr Manish Mistry
• Affiliation: Novartis India Limited

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: 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

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Health Condition 1: null- Myeloproliferative neoplasms

Primary Outcome(s)

To describe the current diagnosis, treatment, pattern

in ET, PV, and MF patients in routine clinical practiceTimepoint: Diagnosis, Treatment patterns (incidence, prevalence,

drug therapy used, duration, reason for

discontinuation, treatment dose adjustment)

Sequencing/changes in therapies

Reason/s to change treatment (including dose

changes)

Time to disease progression from baseline

Secondary Outcome(s)

To describe patient QOL and the association of QOL

with change of therapyTimepoint: QOL

Change in QOL from baseline to change in therapy

Change in QOL from current line of therapy to

subsequent line of therapy

To assess the economic burden captured by medical

resource utilizations using common reference units

(e.g., number of hospital admissions and days in

hospital)Timepoint: Change in frequency of resource utilization from

baseline

Change in frequency of resource utilization from

current line of therapy to subsequent line of therapy

Secondary ID(s)

CINC424AIC01, version 00 Dated 26 Sep 2013

Source(s) of Monetary Support

Novartis Healthcare Private Limited, Sandoz House, Shivsagar Estate, Worli, Mumbai - 400012

Ethics review

Status: Approved
Approval date: 19/02/2014
Contact:

Ethics Committee â?? Apollo Hospitals

Status: Approved
Approval date: 21/02/2014
Contact:

Ethics committee of Care Institute of Medical Sciences,

Status: Approved
Approval date: 15/03/2014
Contact:

Sir Ganga Ram Hospital Ethics Committee

Status: Approved
Approval date: 31/03/2014
Contact:

Institutional Ethics Committee,Institute of Haematology and Transfusion Medicine (IHTM)

Status: Approved
Approval date: 10/05/2014
Contact:

Institutional Review Board, Rajiv Gandhi Cancer Institute & Research center

Status: Approved
Approval date: 30/05/2014
Contact:

Institutional Review Board, Christian Medical College

Status: Approved
Approval date: 02/06/2014
Contact:

Institutional Review Board, Tata Memorial Hospital

Status: Approved
Approval date: 10/06/2014
Contact:

The Ethics Committee, S.M.S. Medical College and Attached Hospitals, SMS Medical College

Status: Approved
Approval date: 26/09/2014
Contact:

SPRIM Human Research and Ethics Committee

Status: Approved
Approval date: 20/10/2014
Contact:

Institute of Ethics Committee - All India Institute of Medical Sciences

Status: Approved
Approval date: 24/10/2014
Contact:

Tata Medical Centre, Institutional Review Board