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Completed

NCT Number: NCT05825326

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

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

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Key information

Conditions

Myeloproliferative Neoplasm Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myeloproliferative Disease, Not Classified Myeloproliferative Disorders Myeloproliferative Neoplasm, Unclassifiable Myeloproliferative Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sociedad de Lucha Contra el Cáncer

Guayaquil, Guayas, Ecuador

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Number of patients with Philadelphia-negative Myeloproliferative Neoplasms in Ecuador

    Time frame: 96 months

    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.

Secondary outcomes

  1. Prevalence of Philadelphia-negative myeloproliferative patients

    Time frame: 96 months

    Calculation of the prevalence of participants who have had Philadelphia-negative Myeloproliferative Neoplasms in Ecuador during the time of observation.

  2. Mortality risk as measured by the Dynamic International Prognostic Scoring System

    Time frame: 96 months

    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.

  3. Overall survival

    Time frame: 96 months

    Percent of participants with Primary Myeloid Fibrosis who were alive at 96 months of follow-up

Sponsors and collaborators

Lead sponsor

Sociedad de Lucha Contra el Cáncer del Ecuador

Other

Registry information

Important dates

Study start
2012
Primary completion
2019
Study completion
2019
First posted
Apr 24, 2023
Registry last updated
Apr 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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