Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador

Study Overview
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Brief Summary
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The goal of this observational study is to evaluate the epidemiological and clinical-pathological features of Philadelphia-negative myeloproliferative neoplasms through data from medical records

Detailed Description
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The investigators are proposing a study that provides descriptive understanding of patients with Philadelphia-negative myeloproliferative neoplasms in Ecuador. The primary objective of this pilot study is to lay the foundations for the development of a multicenter registry of Philadelphia-negative myeloproliferative neoplasms, which will provide high-quality real data and serve as a basis for the application to future projects and elaboration of public policies in the medium and long term.

Official Title
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Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador

Conditions
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Myeloproliferative Neoplasm, Myeloproliferative Syndrome, Myeloproliferative Neoplasm, Unclassifiable, Myeloproliferative Disorders, Myeloproliferative Disease, Not Classified

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years and older Patients with confirmed diagnosis of Philadelphia-negative Myeloproliferative Neoplasms Exclusion Criteria: Patients with translocation t(9;22)(q34:q11.2) with subsequent formation of the BCR-ABL1 fusion gene determined by cytogenetics or fluorescence in situ hybridization (FISH) Absence of the histopathological report in the clinical history and the corresponding plaque, except in the case of Polycythemia Vera that does not require them for diagnosis, according to the 2022 WHO classification

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with Philadelphia-negative Myeloproliferative Neoplasms in Ecuador | Participants were followed-up for 8 years. This is the number of participants who have had Philadelphia-negative Myeloproliferative Neoplasms in Ecuador during the time of observation. | 96 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of Philadelphia-negative myeloproliferative patients | Calculation of the prevalence of participants who have had Philadelphia-negative Myeloproliferative Neoplasms in Ecuador during the time of observation. | 96 months | 
| Mortality risk as measured by the Dynamic International Prognostic Scoring System | The Dynamic International Prognostic Scoring System (DIPSS) was proposed and validated by Passamonti and is used as a prognostic model to predict survival in participants with Primary Myeloid Fibrosis a Philadelphia-negative myeloproliferative neoplasm. Possible scores range from 0 to 6, with higher scores indicating higher mortality risk. | 96 months | 
| Overall survival | Percent of participants with Primary Myeloid Fibrosis who were alive at 96 months of follow-up | 96 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myeloproliferative Neoplasm