Registry of Philadelphia-Negative Myeloproliferative Neoplasms (MPN)

April 1, 2019 updated by: Fabio Pires de Souza Santos, Hospital Israelita Albert Einstein
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Philadelphia-negative (Ph-negative) Myeloproliferative Neoplasms (MPN) include polycythemia vera (PV), essential thrombocythemia (TE), and primary myelofibrosis (MF). Ph-negative MPN are chronic myeloid neoplasms that appear after a malignant transformation of a hematopoietic stem cell. There are many clinical manifestations of these diseases, which include polyglobulia, thrombocytosis, leukocytosis, cytopenias, extramedullary hematopoiesis (e.g.: splenomegaly), increased thrombotic risk and the risk of transformation to acute myeloid leukemia (AML). Life expectancy varies from 5-6 years for patients with MF to more than 15 years for patients with PV and ET.

There are few therapeutic options for patients with Ph-negative MPN. In general, the treatment of these diseases is symptomatic and targeted to the relief of symptoms and control of hematological setting using oral chemotherapy agents such as hydroxyurea. Patients with MF receive palliative treatment, targeted to the relief of splenomegaly and cytopenias. Currently, there are no approved drugs for the treatment of MF.

In Latin America, there are no epidemiological studies with a great number of Ph-negative MPN patients describing the natural history of the disease, patient progress, clinical characteristics, standards of care and disease burden. The development of an up-to-date data registry of Brazilian patients with Ph-negative MPN allows the comprehension of the epidemiology of this disease, with determination of survival, thrombosis incidence, transformation to AML, use of disease treatment-related resources, as well as the impact of different therapeutic strategies in these parameters. Therefore, the objective of this study is to establish a registry of patients with Ph-negative MPN in order to document the disease diagnosis and current standards of care, clinical endpoints, and the use of treatment-related resources, according to risk classification in each MPN.

Data will be retrospectively and prospectively collected through an electronic form available at an Internet safe website. Each center participating in the study will have a principal investigator who will be in charge of the accuracy and quality of the data collected. Each principal investigator and staff will receive a login and a password to access the database and enroll patients in the registry. An employee from each site will be in charge of collecting the data and inserting them in the electronic registry. Patients shall be contacted in order to sign an informed consent form. Patient data will be updated every six months. There is no limit for the number of patients to be enrolled in the registry, either retrospectively or prospectively. The duration of this study is five years. Data collection will continue until all sites decide to interrupt the enrollment of new patients.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Myeloproliferative Neoplasms
Patients diagnosed with Myeloproliferative Neoplasms based on WHO 2008 criteria.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Registry of Philadelphia-Negative Myeloproliferative Neoplasms
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hospital Israelita Albert Einstein

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Federal University of Minas Gerais
Federal University of São Paulo
Hospital Santa Marcelina
Instituto Nacional de Cancer, Brazil
Irmandade da Santa Casa de Misericordia de Sao Paulo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fabio P Santos, Instituto Israelita de Ensino e Pesquisa Albert Einstein´s (IIEP)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2015

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 2, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 2, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 5, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 2, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RMPN2015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hematologic Diseases

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings