Effects of Anti-VEGF Targeted Drugs on Patients' Blood Pr... | NCT04962438

Studies
Effects of Anti-VEGF Targeted Drugs on Patients' Blood Pressure and Endothelial Function

NCT04962438

Sponsor

Peking University Third Hospital

Status

Unknown status

Last Update Posted

Jul 15, 2021Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Cardiac Toxicity
VEGF
Endothelial Dysfunction

Interventions

Anti-VEGF

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

Jun 2021

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 5, 2019Actual

Primary Completion Date

Dec 1, 2021Estimated

Completion Date

Dec 30, 2021Estimated

First Submitted Date

Jun 27, 2021

First Submission Date that Met QC Criteria

Jul 4, 2021

First Posted Date

Jul 15, 2021Actual

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

Jul 4, 2021

Last Update Posted Date

Jul 15, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

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

Explore the effects of anti-VEGF targeted drugs on blood pressure and endothelial function in cancer patients.

Detailed Description

Thirty tumor patients with anti-VEGF drugs were selected. Demographic information and clinical information of all patients were collected before chemotherapy. Ambulatory blood pressure monitoring and endothelial function measurement (PWV, EndoPAT) were performed. Ambulatory blood pressure and PWV were reviewed at 2 weeks and 1 month. And EndoPAT, to evaluate the effects of anti-VEGF drugs on blood pressure and endothelial function in cancer patients.

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

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Tumor patients using anti-VEGF drugs			Drug: Anti-VEGF

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Anti-VEGF	Drug	Anti-tumor drugs targeting the vascular endothelial growth factor (VEGF) signaling pathway	Tumor patients using anti-VEGF drugs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time ending	30 days after using the Anti-VEGF Targeted Drugs	1 month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Tumor patients using anti-VEGF drugs

Exclusion Criteria:

Hypertension, coronary heart disease, valvular heart disease, cardiomyopathy and other organic heart diseases, exclude liver and kidney failure, severe cerebrovascular disease, chronic obstructive pulmonary disease, rheumatic immune system disease

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Thirty tumor patients selected for anti-VEGF drugs, demographic and clinical information of all patients were collected before chemotherapy, ambulatory blood pressure monitoring, endothelial function determination (PWV, EndoPAT)

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Peking University Third Hospital	Recruiting	Beijing	Beijing Municipality	100191	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D066126	Cardiotoxicity

Ancestor Terms

ID	Term
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided