NCT05728788

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

March 3, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

February 6, 2023

Last Update Submit

March 1, 2023

Conditions

Cancer Therapy-related Cardiovascular Toxicity

Outcome Measures

Primary Outcomes (1)

  • At least a 10% decrease in the global longitudinal strain

    The primary endpoint is at least a 10% decrease in the global longitudinal strain, determined using cardiac 2D STE and compared with baseline.

    6 months

Study Arms (1)

Patients treated with antineoplastic agents

50 patients treated with antineoplastic agents will be enrolled.

Drug: Antitumor drugs

Interventions

Antitumor drugsDRUG

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

Patients treated with antineoplastic agents

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with antineoplastic agents

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhenyu Tian

Beijing, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

We will test the collected fecal samples for 16S-rDNA

MeSH Terms

Interventions

Antineoplastic Agents

Intervention Hierarchy (Ancestors)

Therapeutic UsesPharmacologic ActionsChemical Actions and Uses

Study Officials

  • Ming Cui, Doctor

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenyu Tian, Doctor

CONTACT

+8613051871220tzy003@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2023

First Posted

February 15, 2023

Study Start

July 1, 2022

Primary Completion

June 1, 2023

Study Completion

December 1, 2023

Last Updated

March 3, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)