Correlation Between Myocardial Injury and Intestinal Flor... | NCT05728788

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

NCT05728788

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Mar 3, 2023Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Cancer Therapy-related Cardiovascular Toxicity

Interventions

Antitumor drugs

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2022Actual

Primary Completion Date

Jun 1, 2023Estimated

Completion Date

Dec 1, 2023Estimated

First Submitted Date

Feb 6, 2023

First Submission Date that Met QC Criteria

Feb 6, 2023

First Posted Date

Feb 15, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 1, 2023

Last Update Posted Date

Mar 3, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients treated with antineoplastic agents		50 patients treated with antineoplastic agents will be enrolled.	Drug: Antitumor drugs

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Antitumor drugs	Drug	Anthracyclines, immune checkpoint inhibitors, monoclonal antibodies, and tyrosine kinase inhibitors	Patients treated with antineoplastic agents

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients treated with antineoplastic agents

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zhenyu Tian, Doctor	Contact	+8613051871220		tzy003@126.com

Overall Officials

Name	Affiliation	Role
Ming Cui, Doctor	Peking University Third Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zhenyu Tian	Recruiting	Beijing			China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000970	Antineoplastic Agents

Ancestor Terms

ID	Term
D045506	Therapeutic Uses
D020228	Pharmacologic Actions
D020164	Chemical Actions and Uses

Browse Leaves

Not provided

Browse Branches

Not provided