Myeloproliferative NeoplasmNCT05825326
Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
An observational study of Myeloproliferative Neoplasm and Myeloproliferative Syndrome, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm, Myeloproliferative Syndrome, Myeloproliferative Neoplasm, Unclassifiable
- How many people
- 40 participants
- Where
- 1 siteEcuador
- Study dates
- 1 Jan 2012to 31 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms according to the 2022 World Health Organization (WHO) classification
Who may be able to join
- 18 years and older
- Patients with confirmed diagnosis of Philadelphia-negative Myeloproliferative Neoplasms
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Myeloproliferative Neoplasm, Myeloproliferative Syndrome, Myeloproliferative Neoplasm, Unclassifiable, Myeloproliferative Disorders, Myeloproliferative Disease, Not Classified
- Keywords
- Myeloproliferative Neoplasm
- Medical subject headings
- Myeloproliferative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 96 months
Secondary outcomes (3)
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.
Measured: 96 months
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.
Measured: 96 months
Overall survival
Percent of participants with Primary Myeloid Fibrosis who were alive at 96 months of follow-up
Measured: 96 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Jan 2012
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sociedad de Lucha Contra el Cáncer del Ecuador
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fuad Huamán Garaicoa, MD, Principal investigator, Sociedad de Lucha Contra el Cáncer del Ecuador
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05825326
- Sponsor's protocol ID
- CISOLGYE20230022
- Status last verified
- Apr 2023
- First submitted
- 27 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 29212804Heppner 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 31126326Hultcrantz 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 22802311Roaldsnes 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 27500783Arber 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 31659364Linardi 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological and Clinical-pathological Factors of Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
- ClinicalTrials.gov ID
- NCT05825326
- Acronym / sponsor ID
- CISOLGYE20230022
- Conditions
- Myeloproliferative Neoplasm, Myeloproliferative Syndrome, Myeloproliferative Neoplasm, Unclassifiable, Myeloproliferative Disorders, Myeloproliferative Disease, Not Classified
- Keywords
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Sociedad de Lucha Contra el Cáncer del EcuadorUniversity, hospital or other
- Study start
- 1 Jan 2012 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with Philadelphia-negative Myeloproliferative Neoplasms according to the 2022 World Health Organization (WHO) classification
Key inclusion criteria (2 listed)
- 18 years and older
- Patients with confirmed diagnosis of Philadelphia-negative Myeloproliferative Neoplasms
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with Philadelphia-negative Myeloproliferative Neoplasms in Ecuador
Time frame: 96 months
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.
3 secondary outcomes
Prevalence of Philadelphia-negative myeloproliferative patients
Time frame: 96 months
Mortality risk as measured by the Dynamic International Prognostic Scoring System
Time frame: 96 months
Overall survival
Time frame: 96 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Background: PubMed 29212804Nangalia J, Green AR. Myeloproliferative neoplasms: from origins to outcomes. Blood. 2017 Dec 7;130(23):2475-2483. doi: 10.1182/blood-2017-06-782037.
- Background: PubMed 31126326Heppner 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.
- Background: PubMed 22802311Hultcrantz 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.
- Background: PubMed 27500783Roaldsnes 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.
- Background: PubMed 31659364Arber 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.
- Background: PubMed 18425288Linardi 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fuad Huamán Garaicoa, MD principal investigator
Sociedad de Lucha Contra el Cáncer del Ecuador
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myeloproliferative Neoplasm and Myeloproliferative Syndrome, run by Sociedad de Lucha Contra el Cáncer del Ecuador at 1 site in Ecuador.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ecuador. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with Philadelphia-negative Myeloproliferative Neoplasms in Ecuador (time frame: 96 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05825326, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.