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

Myeloproliferative Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05825326
• Other study ID #: CISOLGYE20230022
• Status: Completed
• Start date: January 1, 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: April 2023
• Source: Sociedad de Lucha Contra el Cáncer del Ecuador
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Myeloproliferative Neoplasm, Unclassifiable
• Myeloproliferative Syndrome
• Neoplasms

Locations

Country	Name	City	State
Ecuador	Sociedad de Lucha Contra el Cáncer	Guayaquil	Guayas

Sponsors (1)

Lead Sponsor	Collaborator
Sociedad de Lucha Contra el Cáncer del Ecuador

Country where clinical trial is conducted

Ecuador, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	96 months
Secondary	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.	96 months
Secondary	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.	96 months
Secondary	Overall survival	Percent of participants with Primary Myeloid Fibrosis who were alive at 96 months of follow-up	96 months