NCT05939089

Brief Summary

The goal of this observational study is to evaluate cardiac and vascular health status of pediatric cancer survivors.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
54

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2023

Completed
17 days until next milestone

First Posted

Study publicly available on registry

July 11, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

6 months

First QC Date

June 24, 2023

Last Update Submit

July 8, 2023

Conditions

Left Ventricular DysfunctionHeart Failure

Keywords

Childhood Cancer SurvivorsCardiotoxicitycancer treatment related heart diseases

Outcome Measures

Primary Outcomes (1)

  • Rate of LV Dysfunction

    Echocardiographic evaluation of left ventricular functions

    From the first visit at cardio-oncology division through study completion, an average of 2 years

Interventions

ECG, Echocardiography, cTnI, NT-ProBNPDIAGNOSTIC_TEST

All pediatric cancer survivors are evaluated with cardiological examination, ECG, transthoracic echocardiography (transesophageal echocardiography when required), NT-proBNP, cTnI, kidney function tests, liver function tests, fasting blood glucose, cholesterol panel, iron, iron binding capacity, ferritin, transferrin saturation, B12, vitamin D, folic acid, urinanalysis, hemogram and a questionnaire about living with heart failure.

Eligibility Criteria

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

All patients who are less than 18 years-old, diagnosed and treated for any type of cancer.

You may qualify if:

  • Diagnosed cancer at pediatric age

You may not qualify if:

  • Having cancer after 18 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Faculty of Medicine

Fatih, Istanbul, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Ventricular Dysfunction, LeftHeart FailureCardiotoxicity

Interventions

ElectrocardiographyEchocardiography

Condition Hierarchy (Ancestors)

Ventricular DysfunctionHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDrug-Related Side Effects and Adverse ReactionsChemically-Induced DisordersRadiation InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosisCardiac Imaging TechniquesDiagnostic ImagingUltrasonography

Study Officials

  • Cafer Zorkun, MD PhD

    Faculty member

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head, Division of CardioOncology

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 11, 2023

Study Start

January 1, 2023

Primary Completion

June 15, 2023

Study Completion

June 22, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Locations

TU(1)