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CompletedNCT05825326Updated Apr 27, 2023

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

An observational study in Myeloproliferative Neoplasm, Myeloproliferative Syndrome and Myeloproliferative Neoplasm, Unclassifiable, sponsored by Sociedad de Lucha Contra el Cáncer del Ecuador. Completed at 1 site in Ecuador. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-04-27.

Sponsored by Sociedad de Lucha Contra el Cáncer del Ecuador · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
40
Ages
18 Years and older
Sex
All
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Study 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

Read the 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.

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Conditions studied

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

Keywords

  • Myeloproliferative Neoplasm
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In context

Myeloproliferative Disorders

667 studies on the registry are indexed under Myeloproliferative Disorders; 110 are open to participants now.

This study's enrollment of 40 is below the median of 150 across 115 observational studies indexed under Myeloproliferative Disorders.

Browse Myeloproliferative Disorders studies →

Lead sponsor

Sociedad de Lucha Contra el Cáncer del Ecuador is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms according to the 2022 World Health Organization (WHO) classification

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 18 years and older
  • Patients with confirmed diagnosis of Philadelphia-negative Myeloproliferative Neoplasms

Exclusion criteria

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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
40 participants (actual)
Patient registry
No

Groups and cohorts

  • Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms
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What researchers measure

Primary outcomes

  1. 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.

    Time frame: 96 months

Secondary outcomes

  1. 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.

    Time frame: 96 months

  2. 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.

    Time frame: 96 months

  3. Overall survival

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

    Time frame: 96 months

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Study locations

1 site
  • Sociedad de Lucha Contra el Cáncer
    Guayaquil, Guayas, Ecuador
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References and documents

Publications

  • Nangalia J, Green AR. Myeloproliferative neoplasms: from origins to outcomes. Blood. 2017 Dec 7;130(23):2475-2483. doi: 10.1182/blood-2017-06-782037. PubMed 29212804 ↗
  • Heppner J, Nguyen LT, Guo M, Naugler C, Rashid-Kolvear F. Incidence of myeloproliferative neoplasms in Calgary, Alberta, Canada. BMC Res Notes. 2019 May 24;12(1):286. doi: 10.1186/s13104-019-4321-1. PubMed 31126326 ↗
  • Hultcrantz M, Kristinsson SY, Andersson TM, Landgren O, Eloranta S, Derolf AR, Dickman PW, Bjorkholm M. Patterns of survival among patients with myeloproliferative neoplasms diagnosed in Sweden from 1973 to 2008: a population-based study. J Clin Oncol. 2012 Aug 20;30(24):2995-3001. doi: 10.1200/JCO.2012.42.1925. Epub 2012 Jul 16. PubMed 22802311 ↗
  • Roaldsnes C, Holst R, Frederiksen H, Ghanima W. Myeloproliferative neoplasms: trends in incidence, prevalence and survival in Norway. Eur J Haematol. 2017 Jan;98(1):85-93. doi: 10.1111/ejh.12788. Epub 2016 Sep 4. PubMed 27500783 ↗
  • Arber DA, Orazi A, Hasserjian R, et al. The 2016 revision to the World Health Organization classification of myeloid neoplasms and acute leukemia. Blood. 2016;127(20):2391-2405. Blood. 2016 Jul 21;128(3):462-463. doi: 10.1182/blood-2016-06-721662. No abstract available. PubMed 31659364 ↗
  • Linardi Cda C, Pracchia LF, Buccheri V. Diagnosis and treatment of polycythemia vera: Brazilian experience from a single institution. Sao Paulo Med J. 2008 Jan 2;126(1):52-7. doi: 10.1590/s1516-31802008000100010. PubMed 18425288 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 27, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05825326
Lead sponsor
Sociedad de Lucha Contra el Cáncer del Ecuador
Responsible party
Sponsor
First posted
Apr 24, 2023
Start date
Jan 1, 2012
Primary completion
Dec 31, 2019
Completion
Dec 31, 2019
Last update
Apr 27, 2023

Study contacts

Fuad Huamán Garaicoa, MD
principal investigator · Sociedad de Lucha Contra el Cáncer del Ecuador

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.

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