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Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis (MRMF01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03402399
Recruitment Status : Unknown
Verified July 2019 by Assaf-Harofeh Medical Center.
Recruitment status was:  Recruiting
First Posted : January 18, 2018
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
Assaf-Harofeh Medical Center

Study Description
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Brief Summary:
The aim of the study is to determine the rate of HMR mutations in PMF and secondary MF (post PV/ET) subjects, and correlate the rate of mutations with clinical features as known prognostic scores.

Condition or disease Intervention/treatment Phase
Myelofibrosis, Primary Myelofibrosis, Post PV Myelofibrosis, Post ET Other: Molecular analysis Not Applicable

Detailed Description:

Main inclusion criteria:

  1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
  2. Age ≥ 18 years
  3. Concurrent participation in clinical trials will be allowed.

Efficacy assessments will be evaluated by: HMR mutations rate, specific HMR mutations, disease duration, presence of splenomegaly, cytogenetic risk, DIPPS, IPSS, ET survival score and PV survival score.

The primary efficacy parameter to be assessed will be HMR mutation rate.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 222 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis
Actual Study Start Date : December 10, 2017
Estimated Primary Completion Date : December 9, 2019
Estimated Study Completion Date : December 9, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Primary Myelofibrosis
Blood test
 Other: Molecular analysis
Blood test
Secondary Myelofibrosis
Blood test
 Other: Molecular analysis
Blood test


Outcome Measures
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Primary Outcome Measures :
  1. Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF [ Time Frame: Baseline ]
    Proportions of patients with HMR mutations in each arm


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
  2. Age . 18 years
  3. Patient is willing and capable of giving a written informed consent.
  4. Concurrent participation in clinical trials will be allowed

Exclusion Criteria:

  1. Unwilling or unable to provide informed consent
  2. Prefibrotic MF
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03402399


Contacts
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Contact: Shirly Broitman +972-8-9778452 shirlib@asaf.health.gov.il

Locations
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Israel
Assaf Harofeh Medical Center Recruiting
Zerifin, Israel
Contact: Maya Koren-Michowitz, MD       korenm@asaf.health.gov.il   
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
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Principal Investigator: Maya Koren-Michowitz, MD Assaf-Harofeh Medical Center
More Information
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Responsible Party: Assaf-Harofeh Medical Center
ClinicalTrials.gov Identifier: NCT03402399    
Other Study ID Numbers: 0124-17
First Posted: January 18, 2018    Key Record Dates
Last Update Posted: July 5, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Primary Myelofibrosis
Myeloproliferative Disorders
Bone Marrow Diseases
Hematologic Diseases