Myeloproliferative Neoplasm Clinical Trial
Official title:
Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
Verified date | April 2023 |
Source | Sociedad de Lucha Contra el Cáncer del Ecuador |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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
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 |
Country | Name | City | State |
---|---|---|---|
Ecuador | Sociedad de Lucha Contra el Cáncer | Guayaquil | Guayas |
Lead Sponsor | Collaborator |
---|---|
Sociedad de Lucha Contra el Cáncer del Ecuador |
Ecuador,
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
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 |
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