Philadelphia Chromosome Negative Chronic Myelogenous LeukemiaMetSaMyeloprofNCT07814560
Metabolic Syndrome and Risk of Chronic Philadelphia Negative Myeloproliferative Neoplasms
An observational study of Philadelphia Chromosome Negative Chronic Myelogenous Leukemia, run by Assiut University.
Trial summary
Studying the role of metabolic syndrome in chronic Myeloproliferative neoplasms (MPNs) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Philadelphia Chromosome Negative Chronic Myelogenous Leukemia
- How many people
- 313 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2026to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms
Who may be able to join
- chronic Philadelphia negative Myeloproliferative Neoplasms
Who cannot join
- remission
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Studying the role of metabolic syndrome in chronic Myeloproliferative neoplasms (MPNs)
Read the detailed description
Chronic Myeloproliferative neoplasms (MPNs), such as polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), are defined by clonal myeloid proliferation . Thrombotic events are the leading cause of morbidity and mortality in these patients . Traditional cardiovascular risk factors (CVRFs) critically exacerbate disease severity, accelerate progression to overt myelofibrosis, and significantly reduce overall survival .
Metabolic syndrome components overlap substantially with MPNs; in PV, hypertension affects 39-70%, dyslipidemia 15-38%, diabetes 7-16%, and obesity 7.5% . Epidemiological evidence demonstrates that these factors are independent predictors of arterial and venous thrombosis . while obesity is significantly linked to ET and exacerbates total symptom burden .
The mechanistic link between Metabolic syndrome and MPNs involves the JAK2V617F mutation, which induces constitutive JAK/STAT signaling and alters both lipid and glucose metabolism . MPN clones exhibit a high dependence on glucose, marked by upregulated glycolysis, elevated oxidative phosphorylation, and increased PFKFB3 expression . This metabolic reprogramming, combined with chronic systemic inflammation, cytokine overproduction, and oxidative stress, promotes severe endothelial dysfunction, accelerated atherogenesis, and hypercoagulability .
Current literature assessing different components of Metabolic syndrome in MPNs is limited by methodological gaps, often relying on retrospective data lacking comprehensive baseline metabolic parameters . Therefore, rigorous case-control designs with robust statistical extraction are required. Utilizing standard statistical software environments to perform multivariate adjustments is crucial to properly control for disease heterogeneity.
- Keywords
- Philadelphia chromosome negative
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 |
|---|---|---|
| eligible patients already diagnosed with chronic Philadelphia negative Myeloproliferative Neoplasms | metabolic syndrome |
What is being measured
The primary outcome is the main question the study is designed to answer.
relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms
relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jan 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Philadelphia Chromosome Negative Chronic Myelogenous LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 313 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Hasan Mohammad AbdEllah-Alawi, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07814560
- Sponsor's protocol ID
- MetSaMyeloprof
- Acronym
- MetSaMyeloprof
- Status last verified
- Sep 2026
- First submitted
- 6 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kelem A, Shiferaw E, Adane T. Hematological abnormalities and associated factors among metabolic syndrome patients at the University of Gondar comprehensive specialized hospital, Northwest Ethiopia. PLoS One. 2023 May 25;18(5):e0286163. doi: 10.1371/journal.pone.0286163. eCollection 2023.
PubMed 37228109
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Syndrome and Risk of Chronic Philadelphia Negative Myeloproliferative Neoplasms
- ClinicalTrials.gov ID
- NCT07814560
- Acronym / sponsor ID
- MetSaMyeloprof / MetSaMyeloprof
- Keywords
- Philadelphia chromosome negative
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 313 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 11 Sep 2026 (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.
Studying the role of metabolic syndrome in chronic Myeloproliferative neoplasms (MPNs)
Detailed description
Chronic Myeloproliferative neoplasms (MPNs), such as polycythemia vera (PV), essential thrombocythemia (ET), and primary myelofibrosis (PMF), are defined by clonal myeloid proliferation . Thrombotic events are the leading cause of morbidity and mortality in these patients . Traditional cardiovascular risk factors (CVRFs) critically exacerbate disease severity, accelerate progression to overt myelofibrosis, and significantly reduce overall survival .
Metabolic syndrome components overlap substantially with MPNs; in PV, hypertension affects 39-70%, dyslipidemia 15-38%, diabetes 7-16%, and obesity 7.5% . Epidemiological evidence demonstrates that these factors are independent predictors of arterial and venous thrombosis . while obesity is significantly linked to ET and exacerbates total symptom burden .
The mechanistic link between Metabolic syndrome and MPNs involves the JAK2V617F mutation, which induces constitutive JAK/STAT signaling and alters both lipid and glucose metabolism . MPN clones exhibit a high dependence on glucose, marked by upregulated glycolysis, elevated oxidative phosphorylation, and increased PFKFB3 expression . This metabolic reprogramming, combined with chronic systemic inflammation, cytokine overproduction, and oxidative stress, promotes severe endothelial dysfunction, accelerated atherogenesis, and hypercoagulability .
Current literature assessing different components of Metabolic syndrome in MPNs is limited by methodological gaps, often relying on retrospective data lacking comprehensive baseline metabolic parameters . Therefore, rigorous case-control designs with robust statistical extraction are required. Utilizing standard statistical software environments to perform multivariate adjustments is crucial to properly control for disease heterogeneity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eligible patients already diagnosed with chronic Philadelphia negative Myeloproliferative Neoplasms | – | –metabolic syndrome |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms
Key inclusion criteria (1 listed)
- chronic Philadelphia negative Myeloproliferative Neoplasms
Key exclusion criteria (1 listed)
- remission
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
relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms
Time frame: 6 months
relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Background: PubMed 37228109Kelem A, Shiferaw E, Adane T. Hematological abnormalities and associated factors among metabolic syndrome patients at the University of Gondar comprehensive specialized hospital, Northwest Ethiopia. PLoS One. 2023 May 25;18(5):e0286163. doi: 10.1371/journal.pone.0286163. eCollection 2023.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Philadelphia Chromosome Negative Chronic Myelogenous Leukemia, run by Assiut University.
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 1 inclusion and 1 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: opening soon, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohammad HM AbdEllah-Alawi, Consultant (+201115353591, mhmdifferent@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
relation of metabolic syndrome to clinical course chronic Philadelphia negative Myeloproliferative Neoplasms (time frame: 6 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 NCT07814560, which also lists 1 linked publication.
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 11 Sep 2026.