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

Sponsor
Sociedad de Lucha Contra el Cáncer del Ecuador (Other)
Overall Status
Completed
CT.gov ID
NCT05825326
Collaborator
(none)
40
Enrollment
1
Location
96
Actual Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
    Actual Study Start Date :
    Jan 1, 2012
    Actual Primary Completion Date :
    Dec 31, 2019
    Actual Study Completion Date :
    Dec 31, 2019

    Arms and Interventions

    Arm Intervention/Treatment
    Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms

    Outcome Measures

    Primary Outcome Measures

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

    1. Prevalence of Philadelphia-negative myeloproliferative patients [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 [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 [96 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sociedad de Lucha Contra el Cáncer Guayaquil Guayas Ecuador

    Sponsors and Collaborators

    • Sociedad de Lucha Contra el Cáncer del Ecuador

    Investigators

    • Principal Investigator: Fuad Huamán Garaicoa, MD, Sociedad de Lucha Contra el Cáncer del Ecuador

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Sociedad de Lucha Contra el Cáncer del Ecuador
    ClinicalTrials.gov Identifier:
    NCT05825326
    Other Study ID Numbers:
    • CISOLGYE20230022
    First Posted:
    Apr 24, 2023
    Last Update Posted:
    Apr 27, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Sociedad de Lucha Contra el Cáncer del Ecuador
    Myeloproliferative Neoplasm
    Additional relevant MeSH terms:
    Neoplasms
    Myeloproliferative Disorders

    Study Results

    No Results Posted as of Apr 27, 2023