Thrombocytosis in ChildrenNCT06341036
Aetiology And Outcome Of Children With Thrombocytosis Admitted to Assiut University Children Hospital
An observational study of Thrombocytosis in Children, run by Assiut University.
Trial summary
The primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Thrombocytosis in Children
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2024to 3 Mar 2026
- 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 1 month to 18 years
- All sexes
- Child, Adult
Study population: Children with Thrombocytosis
Who may be able to join
- all patients from age 1 month to 18 years old , who were admitted to Assiut University Children's Hospital with thrombocytosis
Who cannot join
- 1-Neonates ,Children with malignancy , 2Children with polycythemia vera
About this study
The primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children.
Read the detailed description
Thrombocytosis, also called thrombocythemia, is generally defined as a platelet count that is above the upper limit. The most commonly accepted cutoff value for normal is <450,000/μL. Platelet counts in the range of 450,000 to 700,000/μL are considered mild, between 700,000 and 900,000 /μL are considered moderate, between 900,000 and 1,000,000/μL are considered severe, and values above 1,000,000/μL are considered extreme thrombocytosis.The incidence of newly diagnosed primary thrombocytosis in children is about 1 per 10 million, about 60 times lower than adults.
The thrombocytosis is classified into primary thrombocytosis and secondary thrombocytosis. primary thrombocytosis classified into hereditary thrombocytosis which due to mutations in THPO,MPL,JAK2 and acquired primary thrombocytosis which classified into BCR-ABL1negative MPN as :Essential thrombocythemia(ET) , polycythemia vera(pv) ,primary myelofibrosis(PMF).and BCR-ABL1positive disorders but secondary thrombocytosis is due to :bacterial/viral infection,acute phase response ,chronic inflammation ,iron deficiency anemia , hemolytic anemia ,asplenia ,drugs :THPO analoga ,EPO.
Secondary thrombocytosis is commonly seen in children with a variety of clinical conditions. The most common cause of secondary thrombocytosis in children is respiratory infection .According to the World Health Organization guidelines, the persistent diagnosis of essential thrombocythemia requires a platelet count of ≥450,000/μL in patients with thrombocytosis, and it should be determined whether thrombocytosis is primary or secondary. The criteria of the World Health Organization are often used for diagnosis. .
In most cases, the symptoms are due to an underlying disorder and not the thrombocytosis itself. Extreme thrombocytosis may rarely result in thrombotic events such as acute myocardial infarction, mesenteric vein thrombosis, and pulmonary embolism.
The pathophysiology of thrombocytosis is according to each type:
Hereditary forms of primary thrombocytosis are caused by germline mutations within the genes encoding thrombopoietin (THPO), its receptor (MPL), and the receptor's effector kinase Januskinase2 (JAK2) .
Acquired primary thrombocytosis is marked by somatic mutations and occurs in several myeloid malignancies that are more commonly found in adults than in children. Therefore, most of the current knowledge on their pathogenesis and on their clinical management has been derived from studies in adults. Myeloid malignancies that may involve acquired primary thrombocytosis include myeloproliferative (MPNs) and myelodysplastic neoplasms (MDS), such as Philadelphia-positive chronic myeloid leukemia (CML), the Philadelphia-negative neoplasms ET, PV, and PMF, MPN/MDS with ring sideroblasts and thrombocytosis (RARS-T) or MDS with isolated del(5q) syndrome In secondary thrombocytosis , elevated platelet levels result from an extrinsic process, such as acute or chronic inflammation, which stimulates megakaryocytopoiesis . Thrombopoiesis is regulated by the interplay between thrombopoietin (THPO) and its receptor c-Mpl .In secondary thrombocytosis, interleukin-6 (Il-6) constitutes an additional key mediator .
- Conditions
- Thrombocytosis in Children
What is being measured
The primary outcome is the main question the study is designed to answer.
Aetiology And Outcome Of children with Thrombocytosis admitted to Assiut University children hospital
Patient will be classified into two groups according to type primary and secondary. Each group will be compared :
- demographically
- clinically
- on treatment and Outcome
Measured: Basalin
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Jul 2024 (estimated)
- Primary completion3 Mar 2025 (estimated)
- Study completion3 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thrombocytosis in ChildrenStudies 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aya Mamdouh Safina Abid, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341036
- Sponsor's protocol ID
- Thrombocytosis in Children
- Status last verified
- Jan 2024
- First submitted
- 19 Feb 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aetiology And Outcome Of Children With Thrombocytosis Admitted to Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT06341036
- Acronym / sponsor ID
- Thrombocytosis in Children
- Conditions
- Thrombocytosis in Children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Jul 2024 (estimated)
- Primary completion
- 3 Mar 2025 (estimated)
- Study completion
- 3 Mar 2026 (estimated)
- First posted
- 2 Apr 2024 (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 primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children.
Detailed description
Thrombocytosis, also called thrombocythemia, is generally defined as a platelet count that is above the upper limit. The most commonly accepted cutoff value for normal is <450,000/μL. Platelet counts in the range of 450,000 to 700,000/μL are considered mild, between 700,000 and 900,000 /μL are considered moderate, between 900,000 and 1,000,000/μL are considered severe, and values above 1,000,000/μL are considered extreme thrombocytosis.The incidence of newly diagnosed primary thrombocytosis in children is about 1 per 10 million, about 60 times lower than adults.
The thrombocytosis is classified into primary thrombocytosis and secondary thrombocytosis. primary thrombocytosis classified into hereditary thrombocytosis which due to mutations in THPO,MPL,JAK2 and acquired primary thrombocytosis which classified into BCR-ABL1negative MPN as :Essential thrombocythemia(ET) , polycythemia vera(pv) ,primary myelofibrosis(PMF).and BCR-ABL1positive disorders but secondary thrombocytosis is due to :bacterial/viral infection,acute phase response ,chronic inflammation ,iron deficiency anemia , hemolytic anemia ,asplenia ,drugs :THPO analoga ,EPO.
Secondary thrombocytosis is commonly seen in children with a variety of clinical conditions. The most common cause of secondary thrombocytosis in children is respiratory infection .According to the World Health Organization guidelines, the persistent diagnosis of essential thrombocythemia requires a platelet count of ≥450,000/μL in patients with thrombocytosis, and it should be determined whether thrombocytosis is primary or secondary. The criteria of the World Health Organization are often used for diagnosis. .
In most cases, the symptoms are due to an underlying disorder and not the thrombocytosis itself. Extreme thrombocytosis may rarely result in thrombotic events such as acute myocardial infarction, mesenteric vein thrombosis, and pulmonary embolism.
The pathophysiology of thrombocytosis is according to each type:
Hereditary forms of primary thrombocytosis are caused by germline mutations within the genes encoding thrombopoietin (THPO), its receptor (MPL), and the receptor's effector kinase Januskinase2 (JAK2) .
Acquired primary thrombocytosis is marked by somatic mutations and occurs in several myeloid malignancies that are more commonly found in adults than in children. Therefore, most of the current knowledge on their pathogenesis and on their clinical management has been derived from studies in adults. Myeloid malignancies that may involve acquired primary thrombocytosis include myeloproliferative (MPNs) and myelodysplastic neoplasms (MDS), such as Philadelphia-positive chronic myeloid leukemia (CML), the Philadelphia-negative neoplasms ET, PV, and PMF, MPN/MDS with ring sideroblasts and thrombocytosis (RARS-T) or MDS with isolated del(5q) syndrome In secondary thrombocytosis , elevated platelet levels result from an extrinsic process, such as acute or chronic inflammation, which stimulates megakaryocytopoiesis . Thrombopoiesis is regulated by the interplay between thrombopoietin (THPO) and its receptor c-Mpl .In secondary thrombocytosis, interleukin-6 (Il-6) constitutes an additional key mediator .
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Children with Thrombocytosis
Key inclusion criteria (1 listed)
- all patients from age 1 month to 18 years old , who were admitted to Assiut University Children's Hospital with thrombocytosis
Key exclusion criteria (1 listed)
- 1-Neonates ,Children with malignancy , 2Children with polycythemia vera
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
Aetiology And Outcome Of children with Thrombocytosis admitted to Assiut University children hospital
Time frame: Basalin
Patient will be classified into two groups according to type primary and secondary. Each group will be compared : * demographically * clinically * on treatment and Outcome
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Thrombocytosis in Children, 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: status not confirmed, as of the sponsor's last update on 2 Apr 2024. 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?
Results are not available in the source record.
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?
Aetiology And Outcome Of children with Thrombocytosis admitted to Assiut University children hospital (time frame: Basalin). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Apr 2024.