Registry of Philadelphia-Negative Myeloproliferative Neoplasms
NCT ID: NCT02380378
Last Updated: 2019-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2015-03-31
2025-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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OTHER
PROSPECTIVE
Study Groups
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Myeloproliferative Neoplasms
Patients diagnosed with Myeloproliferative Neoplasms based on WHO 2008 criteria.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* refusal to sign the informed consent form (for patients who are alive and will de included in the prospective step of the study.
18 Years
ALL
No
Sponsors
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Hospital Santa Marcelina
OTHER
Instituto Nacional de Cancer, Brazil
OTHER_GOV
Federal University of Minas Gerais
OTHER
Irmandade da Santa Casa de Misericordia de Sao Paulo
OTHER
Federal University of São Paulo
OTHER
Hospital Israelita Albert Einstein
OTHER
Responsible Party
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Fabio Pires de Souza Santos
Fabio Pires de Souza Santos
Principal Investigators
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Fabio P Santos
Role: PRINCIPAL_INVESTIGATOR
Instituto Israelita de Ensino e Pesquisa Albert Einstein´s (IIEP)
Locations
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Hospital Israelita Albert Einstein
São Paulo, São Paulo, Brazil
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RMPN2015
Identifier Type: -
Identifier Source: org_study_id
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