Clinical trial NCT05825326: Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
Official title: Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Myeloproliferative Neoplasm
Myeloproliferative Syndrome
Myeloproliferative Neoplasm, Unclassifiable
Myeloproliferative Disorders
Myeloproliferative Disease, Not Classified
Keywords: Myeloproliferative Neoplasm
Lead sponsor: Sociedad de Lucha Contra el Cáncer del Ecuador
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms according to the 2022 World Health Organization (WHO) classification

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of patients with Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
timeFrame: 96 months
Secondary outcomes:
measure: Prevalence of Philadelphia-negative myeloproliferative patients
timeFrame: 96 months
measure: Mortality risk as measured by the Dynamic International Prognostic Scoring System
timeFrame: 96 months
measure: Overall survival
timeFrame: 96 months
Other outcomes:
Locations:
city: Guayaquil
country: Ecuador
facility: Sociedad de Lucha Contra el Cáncer
state: Guayas
Study officials:
affiliation: Sociedad de Lucha Contra el Cáncer del Ecuador
name: Fuad Huamán Garaicoa, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.