Correlation Between Myocardial Injury and Intestinal Flora Changes Associated With Oncology Drug Therapy

NCT ID: NCT05728788

Last Updated: 2023-03-03

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-07-01

Study Completion Date

2023-12-01

Brief Summary

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The purpose of this study was to explore the relationship between early myocardial injury caused by tumor drug therapy and intestinal microbial structure changes by echocardiographic two-dimensional speckle tracking technique and intestinal microflora structure detection.

Detailed Description

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This is a monocentric prospective cohort study in which 50 patients treated for malignant tumors will be included. All participants will be followed for 6 months after the initiation of oncology drug therapy. Echocardiography and 2D speckle tracking will be performed and stool and blood samples will be tested before treatment initiation and at 3 and 6 months after initiation.

Conditions

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Cancer Therapy-related Cardiovascular Toxicity

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients treated with antineoplastic agents

50 patients treated with antineoplastic agents will be enrolled.

Antitumor drugs

Intervention Type DRUG

Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase inhibitors

Interventions

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Antitumor drugs

Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase inhibitors

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* With malignant tumors
* Will receive antitumor drugs
* Could receive regular follow-up for 6 months
* Written informed consent

Exclusion Criteria

* Satisfactory echocardiographic images could not be obtained
* Cardiomyopathy
* Coronary artery disease
* Heart failure
* Arrhythmia requiring intervention
* Moderate or severe valvular disease
* Acute myocarditis
* Refractory hypertension
* Participating in other studies of drug intervention
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Peking University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ming Cui, Doctor

Role: PRINCIPAL_INVESTIGATOR

Peking University Third Hospital

Locations

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Zhenyu Tian

Beijing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhenyu Tian, Doctor

Role: CONTACT

+8613051871220

Facility Contacts

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Zhenyu Tian

Role: primary

+8613051871220

Other Identifiers

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M2021598

Identifier Type: -

Identifier Source: org_study_id

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