NCT02380378

Brief Summary

This study was developed to document current diagnosis and treatment patterns, clinical outcomes, and health care resource use associated with Philadelphia-Negative Myeloproliferative Neoplasms, in the different risk classifications for each disease.

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
500

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Longer than P75 for all trials

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

March 1, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 5, 2015

Completed
7.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

April 2, 2019

Status Verified

April 1, 2019

Enrollment Period

7.8 years

First QC Date

March 2, 2015

Last Update Submit

April 1, 2019

Conditions

Hematologic Diseases

Outcome Measures

Primary Outcomes (1)

  • Registry of Philadelphia-Negative Myeloproliferative Neoplasms

    5 years

Study Arms (1)

Myeloproliferative Neoplasms

Patients diagnosed with Myeloproliferative Neoplasms based on WHO 2008 criteria.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are followed in hematological centers with confirmed diagnosis of Myeloproliferative Neoplasms since 2000.

You may qualify if:

  • diagnosis of (according to WHO 2008 criteria) Polycythemia Vera, Essential Thrombocythemia, Primary Myelofibrosis or Post-Polycythemia Vera/Post-Essential Thrombocythemia Myelofibrosis, Unclassifiable Myeloproliferative Neoplasm, Chronic Neutrophilic Leukemia, Chronic Eosinophilic Leukemia, Systemic Mastocytosis
  • diagnosis made since 2000
  • patients who are being followed-up or not
  • signed informed consent form (for alive patients included in the prospective step of the study).

You may not qualify if:

  • diagnosis of Chronic Myelogenous Leukemia
  • refusal to sign the informed consent form (for patients who are alive and will de included in the prospective step of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Israelita Albert Einstein

São Paulo, São Paulo, 05651901, Brazil

RECRUITING

MeSH Terms

Conditions

Hematologic Diseases

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Study Officials

  • Fabio P Santos

    Instituto Israelita de Ensino e Pesquisa Albert Einstein´s (IIEP)

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio P Santos

CONTACT

fabiopss@gmail.com

Tarcila S Datoguia

CONTACT

tarcila.datoguia@einstein.br

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Fabio Pires de Souza Santos

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 5, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2022

Study Completion

April 1, 2025

Last Updated

April 2, 2019

Record last verified: 2019-04

Locations

BR(1)