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

Completed

• Conditions: Myeloproliferative Neoplasm, Unclassifiable; Myeloproliferative Disease, Not Classified; Myeloproliferative Syndrome; Myeloproliferative Neoplasm; Myeloproliferative Disorders

• Registration Number: NCT05825326
• Lead Sponsor: Sociedad de Lucha Contra el Cáncer del Ecuador

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

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 Timeline

• Study Start: 2012-01-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2023-03-27
• Status Verified: 2023-04
• Study First Submitted QC: 2023-04-10
• Study First Posted: 2023-04-24
• Last Update Submitted: 2023-04-25
• Last Update Posted: 2023-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
Overall survival	96 months	Percent of participants with Primary Myeloid Fibrosis who were alive at 96 months of follow-up

Trial Locations

Locations (1)

Sociedad de Lucha Contra el Cáncer; 🇪🇨 Guayaquil, Guayas, Ecuador