Machine-learning Based Prediction Model in Primary Immune Thrombocytopenia
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|ClinicalTrials.gov Identifier: NCT05116423|
Recruitment Status : Recruiting
First Posted : November 11, 2021
Last Update Posted : February 8, 2022
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|Condition or disease|
|Immune Thrombocytopenia ITP|
Primary immune thrombocytopenia (ITP) is a common acquired autoimmune disease characterized by reduced platelet production and increased platelet destruction due to autoimmune disorders, as patients present with low platelet counts and a high risk of bleeding. Although most ITP patients present a good prognosis, the rare but important critical ITP bleeds events are the threatening-life complication to ITP patients, severely affecting their prognosis, quality of life and treatment decisions.
More recently, the development of clinical prediction models has provided powerful tools for precision diagnosis and early intervention of diseases, especially the application of machine learning methods. Machine learning approaches can overcome some of the limitations of current risk prediction analysis methods by applying computer algorithms to large data sets with numerous multidimensional variables, capturing the high-dimensional nonlinear relationships between clinical features to produce data, drive outcome prediction.
It suggests an unmet need for personalized patient management strategies and an urgent need for effective tools to predict the risk of critical ITP bleeds in hospitalized patients in medical practice.
Here, we aim to integrate clinical and laboratory data based on a nationwide multicenter study in China to build a clinical prediction model. In particular, we also perform external and prospective validation with large sample sizes to improve the robustness and utility of our models.
It is a simple and convenient tool to quickly assess newly admitted ITP patients and achieve early identification and intervention for those at high risk of life-threatening bleeding events, thus reducing disability and mortality rates in the future.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Personalized Machine-Learning Based Prediction Model for Bleeding in Immune Thrombocytopenia: a Nationwide Representative Data Study|
|Actual Study Start Date :||November 10, 2021|
|Estimated Primary Completion Date :||March 1, 2022|
|Estimated Study Completion Date :||June 30, 2022|
The study population included nonsplenectomized primary ITP inpatients 18 years of age or older. Patients who had a diagnosis of connective tissue disease, cancer (solid tumor or leukemia), or primary immune deficiency were excluded.
- Performance of model [ Time Frame: 3 months ]Area under receiver operating characteristic curve (AUC) of the model in predicting critical ITP bleeds in patients with ITP.
- Comparison between different machine learning algorithms used in the model [ Time Frame: 3 months ]Comparison of sensitivity and specificity of different machine learning algorithms used in the model.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Probability Sample|
1. Confirmed ITP diagnosis;
- Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 6 months before the screening visit;
- Current HIV infection or hepatitis B virus or hepatitis C virus infections;
- Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period; a history of clinically significant adverse reactions to previous corticosteroid therapy
- Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test;
- Patients who are deemed unsuitable for the study by the investigator.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05116423
|Contact: Xiao-Hui Zhang, MDemail@example.com|
|Contact: Zhuo-Yu An, MDfirstname.lastname@example.org|
|Peking University Insititute of Hematology, Peking University People's Hospital||Recruiting|
|Beijing, Beijing, China, 100010|
|Contact: Xiao-Hui Zhang, MD email@example.com|
|Contact: Zhuo-Yu An, MD 15010638916 firstname.lastname@example.org|
|Principal Investigator:||Xiao-Hui Zhang, MD||Peking University People's Hospital, Peking University Institute of Hematology, National Clinical Research Center for Hematologic Disease, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Collaborative Innovation Center of Hematology|
|Responsible Party:||Xiao Hui Zhang, Vice President of Peking University Institute of Hematology, Peking University People's Hospital|
|Other Study ID Numbers:||
|First Posted:||November 11, 2021 Key Record Dates|
|Last Update Posted:||February 8, 2022|
|Last Verified:||January 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Immune System Diseases
Purpura, Thrombocytopenic, Idiopathic
Blood Platelet Disorders
Blood Coagulation Disorders