NCT05825326

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

March 27, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 24, 2023

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

8 years

First QC Date

March 27, 2023

Last Update Submit

April 25, 2023

Conditions

Keywords

Myeloproliferative Neoplasm

Outcome Measures

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.

    96 months

Secondary Outcomes (3)

  • Prevalence of Philadelphia-negative myeloproliferative patients

    96 months

  • Mortality risk as measured by the Dynamic International Prognostic Scoring System

    96 months

  • Overall survival

    96 months

Study Arms (1)

Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sociedad de Lucha Contra el Cáncer

Guayaquil, Guayas, Ecuador

Location

Related Publications (6)

  • 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.

    PMID: 29212804BACKGROUND
  • 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.

    PMID: 31126326BACKGROUND
  • 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.

    PMID: 22802311BACKGROUND
  • 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.

    PMID: 27500783BACKGROUND
  • 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.

    PMID: 31659364BACKGROUND
  • 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.

    PMID: 18425288BACKGROUND

MeSH Terms

Conditions

Myeloproliferative Disorders

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Fuad Huamán Garaicoa, MD

    Sociedad de Lucha Contra el Cáncer del Ecuador

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2023

First Posted

April 24, 2023

Study Start

January 1, 2012

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations