NCT03402399

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
222

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 10, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 11, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 18, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 9, 2020

Completed
Last Updated

July 5, 2019

Status Verified

July 1, 2019

Enrollment Period

2 years

First QC Date

January 11, 2018

Last Update Submit

July 2, 2019

Conditions

Myelofibrosis, PrimaryMyelofibrosis, Post PVMyelofibrosis, Post ET

Outcome Measures

Primary Outcomes (1)

  • Rate of patients with one or more HMR mutations in primary compared to secondary (post PV/ET) MF

    Proportions of patients with HMR mutations in each arm

    Baseline

Study Arms (2)

Primary Myelofibrosis

OTHER

Blood test

Other: Molecular analysis

Secondary Myelofibrosis

OTHER

Blood test

Other: Molecular analysis

Interventions

Molecular analysisOTHER

Blood test

Primary MyelofibrosisSecondary Myelofibrosis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Unwilling or unable to provide informed consent
  • Prefibrotic MF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assaf Harofeh Medical Center

Ẕerifin, Israel

RECRUITING

MeSH Terms

Conditions

Primary Myelofibrosis

Condition Hierarchy (Ancestors)

Myeloproliferative DisordersBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Maya Koren-Michowitz, MD

    Assaf-Harofeh Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Shirly Broitman

CONTACT

+972-8-9778452shirlib@asaf.health.gov.il

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2018

First Posted

January 18, 2018

Study Start

December 10, 2017

Primary Completion

December 9, 2019

Study Completion

December 9, 2020

Last Updated

July 5, 2019

Record last verified: 2019-07

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)