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Aetiology And Outcome Of Children With Thrombocytosis Admitted to Assiut University Children Hospital

Study Purpose

The primary Aim :to determine the etiology of thrombocytosis in children and frequency, outcome of thrombocytosis in Children.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 1 Month - 18 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

all patients from age 1 month to 18 years old , who were admitted to Assiut University Children's Hospital with thrombocytosis.

Exclusion Criteria:

1-Neonates ,Children with malignancy , 2_Children with polycythemia vera

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06341036
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Thrombocytosis in Children
Additional Details

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 .

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

For additional contact information, you can also visit the trial on clinicaltrials.gov.

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