Myeloproliferative NeoplasmNCT05993052
Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms
An observational study of Myeloproliferative Neoplasm, run by Sohag University at 1 site in Egypt.
Trial summary
In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT signaling is identified [3, 4]. The JAK/STAT pathway transduces signals from cytokines including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A point mutation that activates JAK2, JAK2V617F, is present… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myeloproliferative Neoplasm
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2022to Sep 2023
- 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
- Adult, Older adult
Study population: patients with Philadelphia negative myeloproliferative neoplasms who were diagnosed according to the WHO 2016 criteria, at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.
Who may be able to join
- All patients aged 18 years and older who were newly diagnosed to have Philadelphia negative myeloproliferative neoplasms between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.
Who cannot join
- Patients were excluded if: (1) their disease of thrombocytosis or polycythemia was determined to be reactive, (2) their disease was not newly diagnosed, (3) their disease met WHO criteria for chronic or acute myeloid leukemia.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Sohag
Mahmoud Gaber, +201007399833, mahmoudgaber@med.sohag.edu.eg
About this study
Official title: Neutrophil-Lymphocyte Ratio and Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms and Their Relation to JAK2V617F Mutation
In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT signaling is identified [3, 4]. The JAK/STAT pathway transduces signals from cytokines including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A point mutation that activates JAK2, JAK2V617F, is present in around 95% of patients with PV and 40% to 60% of patients with ET and MF
Read the detailed description
All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile. All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden.
The control group will undergo carotid ultrasonography who will be recruited among apparently healthy volunteers aiming to match the patient group regarding age, sex and classical risk factors for atherosclerosis as arterial hypertension, hyperlipidemia, diabetes, smoking or obesity.
- Conditions
- Myeloproliferative Neoplasm
- Medical subject headings
- Myeloproliferative Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms
All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile.
Measured: baseline
Carotid Plaque Burden in Patients with Philadelphia Negative Myeloproliferative Neoplasms
All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden. Extracranial carotid arteries were divided into three sectors on each side: common carotid artery and its bulb, internal carotid artery, and external carotid artery. At least one plaque in any sector was scored 1 point, while the absence of plaques was scored 0. Thus, the carotid plaque score ranged from 0 (absence of plaques) to 6 (plaques in all sectors)
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2023
- Study start15 Dec 2022
- Primary completionAug 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myeloproliferative NeoplasmStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Gaber Mahmoud, Sohag University
- Investigators
- Mahmoud Gaber, Principal investigator, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05993052
- Sponsor's protocol ID
- Carotid Doppler in MPNs
- Status last verified
- Aug 2023
- First submitted
- 6 Aug 2023
- Last updated
- 15 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Accorsi F. Color Doppler of the extracranial and intracranial arteries in the acute phase of cerebral ischemia. J Ultrasound. 2013 Sep 21;16(4):187-93. doi: 10.1007/s40477-013-0036-7. eCollection 2013 Sep 21.
PubMed 24432173Kralovics R, Passamonti F, Buser AS, Teo SS, Tiedt R, Passweg JR, Tichelli A, Cazzola M, Skoda RC. A gain-of-function mutation of JAK2 in myeloproliferative disorders. N Engl J Med. 2005 Apr 28;352(17):1779-90. doi: 10.1056/NEJMoa051113.
PubMed 15858187
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neutrophil-Lymphocyte Ratio and Carotid Plaque Burden in Patients With Philadelphia Negative Myeloproliferative Neoplasms and Their Relation to JAK2V617F Mutation
- ClinicalTrials.gov ID
- NCT05993052
- Acronym / sponsor ID
- Carotid Doppler in MPNs
- Conditions
- Myeloproliferative Neoplasm
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Aug 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 15 Aug 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.
In around 90% of the patients with MPNs, an acquired mutation that promotes JAK/STAT signaling is identified [3, 4]. The JAK/STAT pathway transduces signals from cytokines including erythropoietin, thrombopoietin, and granulocyte colony-stimulating factor.24 A point mutation that activates JAK2, JAK2V617F, is present in around 95% of patients with PV and 40% to 60% of patients with ET and MF
Detailed description
All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile. All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden.
The control group will undergo carotid ultrasonography who will be recruited among apparently healthy volunteers aiming to match the patient group regarding age, sex and classical risk factors for atherosclerosis as arterial hypertension, hyperlipidemia, diabetes, smoking or obesity.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients with Philadelphia negative myeloproliferative neoplasms who were diagnosed according to the WHO 2016 criteria, at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.
Key inclusion criteria (1 listed)
- All patients aged 18 years and older who were newly diagnosed to have Philadelphia negative myeloproliferative neoplasms between September 2014 and November 2022 at Sohag university hospital, department of internal medicine, hematology unit and hematology outpatient clinic.
Key exclusion criteria (1 listed)
- Patients were excluded if: (1) their disease of thrombocytosis or polycythemia was determined to be reactive, (2) their disease was not newly diagnosed, (3) their disease met WHO criteria for chronic or acute myeloid leukemia.
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
Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms
Time frame: baseline
All patients will be subjected to a thorough assessment of history, complete clinical examination, and investigations as complete blood picture including neutrophil-lymphocyte ratio which will be analyzed with automated blood count analyzers, serum uric acid, serum creatinine and lipid profile.
Carotid Plaque Burden in Patients with Philadelphia Negative Myeloproliferative Neoplasms
Time frame: baseline
All patients will undergo carotid imaging using Colour Doppler ultrasonography for assessment of carotid plaque burden. Extracranial carotid arteries were divided into three sectors on each side: common carotid artery and its bulb, internal carotid artery, and external carotid artery. At least one plaque in any sector was scored 1 point, while the absence of plaques was scored 0. Thus, the carotid plaque score ranged from 0 (absence of plaques) to 6 (plaques in all sectors)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2023.
- Background: PubMed 24432173Accorsi F. Color Doppler of the extracranial and intracranial arteries in the acute phase of cerebral ischemia. J Ultrasound. 2013 Sep 21;16(4):187-93. doi: 10.1007/s40477-013-0036-7. eCollection 2013 Sep 21.
- Background: PubMed 15858187Kralovics R, Passamonti F, Buser AS, Teo SS, Tiedt R, Passweg JR, Tichelli A, Cazzola M, Skoda RC. A gain-of-function mutation of JAK2 in myeloproliferative disorders. N Engl J Med. 2005 Apr 28;352(17):1779-90. doi: 10.1056/NEJMoa051113.
Related trials for Myeloproliferative Neoplasm
RecruitingPhase 1
Vididencel in CML-CP Patients With MRD
CML (Chronic Myelogenous Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
RecruitingPhase 1/2
Pacritinib, a Kinase Inhibitor of CSF1R, IRAK1, JAK2, and FLT3, in Adults and Pediatric Participants 12 Years of Age or Older With Myelodysplastic Syndromes or Myelodysplastic/Myeloproliferative Neoplasms
Myelodysplastic Syndromes
RecruitingPhase 3
A Phase 3 Study of Pelabresib (DAK539) and Ruxolitinib in Myelofibrosis (MF)
Primary Myelofibrosis (PMF), Post-polycythemia Vera Myelofibrosis (PPV-MF)
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
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.
Mahmoud Gaber principal investigator
Sohag University
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, run by Sohag University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 15 Aug 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Gaber, dr (+201007399833, mahmoudgaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neutrophil-Lymphocyte Ratio in Patients with Philadelphia Negative Myeloproliferative Neoplasms (time frame: baseline). The study lists 2 primary outcomes in all. 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 NCT05993052, which also lists 2 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 15 Aug 2023.