Early Prediction and Warning for Cardiotoxicity Due to Anthracycline-Based Breast Cancer Chemotherapy
NCT ID: NCT06282796
Last Updated: 2024-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2024-01-01
2028-12-31
Brief Summary
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Detailed Description
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Echocardiography has the advantages of real-time, non-invasive and repeatable, and is the preferred detection method for asymptomatic CTRCD at present. The diagnosis of asymptomatic CTRCD depends on the change of left ventricular (LV) ejection fraction (EF) and global longitudinal strain (GLS) before and after chemotherapy. However, the measurement of LVEF and GLS is based on manual methods, resulting in poor repeatability. Cardiotoxicity due to anthracycline-based breast cancer chemotherapy progresses gradually and changes dynamically with dose and time.
Therefore, this study intends to build an intelligent model for early prediction and warning of asymptomatic CTRCD, so as to provide a reliable basis for timely adjustment of individualized cardiac protection strategies and maintaining LV function and reducing mortality.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Anthracycline-Based Breast Cancer Chemotherapy Group
Age ≥18 years, histologically or cytopathologically confirmed stage I-III HER2+ breast cancer, scheduled to receive consecutive anthracycline chemotherapy or subsequent sequential trastuzumab targeted therapy, with a prechemotherapy LVEF≥53%.
Echocardiography
Two-dimensional, color Doppler, spectral Doppler, tissue Doppler and three-dimensional echocardiographic image recordings will be taken using a Philips Epiq 7C echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed by TomTec AutoStrain Suite Software
Interventions
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Echocardiography
Two-dimensional, color Doppler, spectral Doppler, tissue Doppler and three-dimensional echocardiographic image recordings will be taken using a Philips Epiq 7C echocardiography device and X5-1 probe. Conventional parameters, additional parameters, and strain analyzes will be performed by TomTec AutoStrain Suite Software
Eligibility Criteria
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Inclusion Criteria
* Histologically or cytopathological confirmed stage I-III HER2+ breast cancer, scheduled to receive consecutive anthracycline chemotherapy or subsequent sequential trastuzumab targeted therapy
* LVEF≥53% before chemotherapy
Exclusion Criteria
* Participating in other ongoing oncology clinical trials
* Prior treatment with anthracyclines or chest radiation therapy
* Pregnant or lactating women
* Ultrasound images of the heart are of very poor quality
18 Years
80 Years
FEMALE
No
Sponsors
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First Hospital of China Medical University
OTHER
Responsible Party
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Chunyan Ma
Chief of Cardiovascular Ultrasound
Principal Investigators
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Yonghuai Wang, Ph.D
Role: PRINCIPAL_INVESTIGATOR
the First Hospital of China Medical Univeristy
Locations
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Fujian Cancer Hospital
Fuzhou, Fujian, China
Dalian Friendship Hospital
Dalian, Liaoning, China
Dalian Municipal Central Hospital
Dalian, Liaoning, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China
The Third People's Hospital Of Chengdu
Chengdu, Sichuan, China
Countries
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Central Contacts
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Facility Contacts
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Weiqin Huang
Role: primary
Bo Zhang
Role: primary
Qingxiong Yue
Role: primary
Xiaoxue Zhang
Role: primary
Min Xu
Role: primary
Other Identifiers
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EPW-CABC-01
Identifier Type: -
Identifier Source: org_study_id
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