NCT07382141

Brief Summary

To test whether the implementation of new diagnostic techniques (ultrasonography, speckle tracking, vascular stiffness study, cardiac MRI, and histologic studies) allows in CAYA (Childern, Adolescents, and Young Adults) cancer survivors a more sensitive and earlier identification of cardiovascular damage resulting from antineoplastic therapy that develops either acutely or remotely after completion of antineoplastic therapy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
32mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

5 active sites

Status
recruiting

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 Progress30%
Mar 2025Dec 2028

Study Start

First participant enrolled

March 17, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 26, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

February 2, 2026

Status Verified

March 1, 2025

Enrollment Period

3.8 years

First QC Date

January 26, 2026

Last Update Submit

January 26, 2026

Conditions

Keywords

cardiotoxicity

Outcome Measures

Primary Outcomes (1)

  • Incidence of cardiovascular events in CAYA cancer survivors during treatment and follow-up

    Number of cardiovascular events, defined according to ESC 2022 guidelines (Eur Heart J. 2022;43:4229-4361), detected during treatment and follow-up. Time to occurrence of events will be measured relative to pre-treatment evaluation.

    From initiation of antineoplastic therapy up to 12 months post-therapy

Interventions

VICORDER© is a noninvasive, quick and painless technique to be able to assess vascular elasticity and consists of placing a few sphygmomanometers (the same ones used to measure blood pressure) for a few minutes

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of oncological pathology and need for antineoplastic treatment

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

IRCCS - AOU di Bologna -Policlinico di Sant'Orsola UOC Pediatria

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Cardiochirurgia pediatrica e dell'età evolutiva

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS AOU di Bologna -Policlinico di Sant'Orsola UO Oncoematologia Pediatrica

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Cardiologia Pediatria e dell'età evolutiva

Bologna, Bologna, 40138, Italy

RECRUITING

IRCCS AOU di Bologna Policlinico di Sant'Orsola UO Radiologia, sezione Cardio-Toraco-Vascolare

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Andrea Donti, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2026

First Posted

February 2, 2026

Study Start

March 17, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

February 2, 2026

Record last verified: 2025-03

Locations