Defining the Molecular Risk in Israeli Patients With Seco... | NCT03402399

Studies
Defining the Molecular Risk in Israeli Patients With Secondary Compared to Primary Myelofibrosis

NCT03402399

Sponsor

Assaf-Harofeh Medical Center

Status

Unknown status

Last Update Posted

Jul 5, 2019Actual

Enrollment

222Estimated

Phase

Not Applicable

Conditions

Myelofibrosis, Primary
Myelofibrosis, Post PV
Myelofibrosis, Post ET

Interventions

Molecular analysis

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 10, 2017Actual

Primary Completion Date

Dec 9, 2019Estimated

Completion Date

Dec 9, 2020Estimated

First Submitted Date

Jan 11, 2018

First Submission Date that Met QC Criteria

Jan 11, 2018

First Posted Date

Jan 18, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 2, 2019

Last Update Posted Date

Jul 5, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Main inclusion criteria:

Diagnosis of PMF, post PV MF or post ET MF according to the WHO 2008 classification
Age ≥ 18 years
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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

222Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Primary Myelofibrosis	Other	Blood test	Other: Molecular analysis
Secondary Myelofibrosis	Other	Blood test	Other: Molecular analysis

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Molecular analysis	Other	Blood test	Primary Myelofibrosis Secondary Myelofibrosis

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Unwilling or unable to provide informed consent
Prefibrotic MF

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Shirly Broitman	Contact	+972-8-9778452		shirlib@asaf.health.gov.il

Overall Officials

Name	Affiliation	Role
Maya Koren-Michowitz, MD	Assaf-Harofeh Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assaf Harofeh Medical Center	Recruiting	Ẕerifin			Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D055728	Primary Myelofibrosis

Ancestor Terms

ID	Term
D009196	Myeloproliferative Disorders
D001855	Bone Marrow Diseases
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided