Clinical Research Directory

Construction and Multicenter External Validation of an Early Warning Model for Asymptomatic PICC-related Upper Extremity Venous Thrombosis in Cancer Patients Based on LASSO-XGBoost

Sponsor: Zhongnan Hospital

Summary

You will be invited to participate in a clinical study. This informed consent form provides you with some information to help you decide whether to participate in this clinical study. Please read carefully. If you have any questions, please raise them to the researcher in charge of this study. Your participation in this study is voluntary. This research has been reviewed and approved by the Medical Ethics Committee of our hospital. Research objective: peripherally inserted central catheter (PICC) is a commonly used intravenous treatment approach for cancer patients, but catheter-related thrombosis (CRT) is prone to occur after catheterization. Among them, asymptomatic venous thrombosis (referred to as asymptomatic thrombosis) is easily overlooked due to its high concealment and lack of typical clinical manifestations. If not detected and intervened in time, it may lead to serious complications. At present, there is still a lack of effective risk early warning tools specifically for asymptomatic thrombosis related to PICC in tumor patients both at home and abroad. This study aims to collect your clinical data and ultrasound image data to clarify the epidemiological characteristics of the thrombosis, identify its independent risk factors, and construct a high-precision, clinically interpretable joint early warning model, with the goal of providing clinicians with more accurate risk assessment tools and achieving early identification and stratified management of high-risk patients. Ultimately, it reduces the incidence of thrombosis and improves the prognosis of patients. Research Process: If you agree to participate in this study, we will collect your baseline clinical data, past medical history, tumor diagnosis and treatment, PICC catheterization, and complete set of routine test data. We will conduct color Doppler ultrasound examinations of your upper limb blood vessels before the day of catheterization and on the 7th, 14th, 30th, and 60th days after catheterization, record vascular blood flow parameters, and screen for asymptomatic thrombosis. We will number each participant and establish a medical record file. This study plans to recruit 1,655 people. The study period starts from the date you sign the informed consent form and the first PICC catheterization and ends at the completion of the last follow-up 60 days after catheterization. Risks and Discomforts: ① This study only uses conventional clinical ultrasound follow-up, which is radiation-free, non-invasive, will not harm your body, and there is no risk of medical harm. ② The fractional ultrasound examination, combined with data collection, will take up a little of your time and will not bring you additional examination fees. We will strictly protect all your personal information. However, in theory, there is a very small possibility of information leakage. Our hospital will adopt multiple confidentiality measures to minimize this risk to the greatest extent. Benefits: ① Color Doppler ultrasound of the upper limb before catheterization is a mandatory preoperative procedure for PICC catheterization. The cost is already included in your original surgical fee and no additional charges will be applied. At the same time, during the follow-up period after catheterization, you can enjoy four free full-cycle vascular thrombosis ultrasound screenings of the upper limb (on the 7th, 14th, 30th, and 60th days after catheterization). Multiple vascular screenings throughout the process can detect hidden asymptomatic thrombosis as early as possible, allowing for timely intervention and avoiding serious risks such as treatment interruption and pulmonary embolism caused by thrombosis. Your medical record data can assist in the clinical development of simple thrombosis risk assessment tools. In the future, patients with similar tumors undergoing catheterization can quickly predict thrombosis risks, reduce excessive color Doppler ultrasound examinations, and save time and examination costs. Privacy issue: Your relevant medical records will be kept at the hospital. Only researchers, research authorities, and ethics committees are permitted to access your medical records. Any public reports regarding the results of this study will not disclose your personal identity. We will make every effort to protect the privacy of your personal medical information within the scope permitted by law. You may choose not to participate in this study, or notify the researcher at any time to withdraw from the study. Your data will not be included in the study results, and your medical benefits and rights will not be affected as a result. As a research subject, you have the following responsibilities: to provide true information about your medical history and current physical condition; Inform the research doctor of any discomfort you experienced during this study period; Do not take restricted drugs, foods, etc. Inform the research doctor whether you have participated in other studies recent

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