CClinicalTrials.gg
Not yet recruitingNCT07408362CTRCT-pediaUpdated Feb 13, 2026

Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Cancer Therapies

An interventional study of Ergospirometry in Cancer Therapy-related Cardiovascular Toxicity, Childhood Cancer and Chemotherapeutic Toxicity, sponsored by Centre Hospitalier Universitaire de Liege. Not yet recruiting. Open to participants aged 2 Years to 25 Years. Per ClinicalTrials.gov, last updated 2026-02-13.

Sponsored by Centre Hospitalier Universitaire de Liege · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
2 Years to 25 Years
Sex
All
01

Study summary

The goal of this prospective interventional study is to improve the detection of subclinical chronic Cancer Therapy-Related Cardiovascular Toxicity (CTRCT) and evaluate the added value of advanced cardioechography, ergospirometry, and specific biomarkers in pediatric cancer survivors (aged 2 to 25) who received potentially cardiotoxic treatments (chemotherapy/thoracic radiotherapy). The main questions it aims to answer are:

  • Can advanced echocardiography (including strain and myocardial work), ECG, and ergospirometry effectively diagnose earlier subclinical cardiac impairment in this population?
  • What is the prevalence of cardiovascular risk factors (including physical activity levels and biological markers like proBNP/troponins)
  • Can new genetic or biological markers be identified to help optimizing the detection of CTRCT?

At time of follow-up, if they agree, participants will:

  • Complete validated questionnaires regarding quality of life, physical activity, and sedentary behavior.
  • Undergo a cardiopulmonary exercise test (ergospirometry) for those aged over 8 years.
  • Wear an accelerometer (ActiGraph GT3X) for 7 consecutive days to monitor physical activity.
  • Provide an additional blood sample during routine follow-up for the creation of a biobank dedicated to analyzing markers of senescence, fibrosis, apoptosis, and genetic polymorphisms.
02

Conditions studied

  • Cancer Therapy-related Cardiovascular Toxicity
  • Childhood Cancer
  • Chemotherapeutic Toxicity
  • Radiotherapy Side Effect
  • Cardiovascular Complication
03

In context

Neoplasms

9,365 studies on the registry are indexed under Neoplasms; 2,489 are open to participants now.

This study's planned enrollment of 100 is above the median of 50 across 7,253 interventional studies indexed under Neoplasms.

Browse Neoplasms studies →

Lead sponsor

Centre Hospitalier Universitaire de Liege is the lead sponsor of 37 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 25 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of chemotherapy and/or radiotherapy for an oncological condition or bone marrow transplantation (hematologic disease) after 01/01/2016.
  • Age \< 18 years at the time of treatment.
  • Cancer remission for more than one year.
  • Voluntary participation following comprehensive informed consent.
  • Signed informed consent from the patient (≥ 18 years) or from parents/legal guardians, with signed assent for minors aged 8 to 17.

Exclusion criteria

Exclusion Criteria:

  • Active disease recurrence or relapse.
  • Current administration of antineoplastic therapy.
  • Withdrawal of consent or refusal to participate by the patient or their legal representatives.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Experimental
    Pediatric Cancer Survivors in CHU Liege

    Patients aged 2 to 25 years followed at CHU de Liège, who have received potentially cardiotoxic treatment (chemotherapy and/or thoracic radiotherapy) for pediatric cancer or bone marrow transplantation since January 1st, 2016 and are in remission for at least 1 year.

    Diagnostic Test: Ergospirometry

Interventions

  • Diagnostic testErgospirometry

    Completion of validated, age-appropriate quality of life scales and physical activity assessment forms. Patients over 8 years of age will perform a standardized cardiopulmonary exercise test (CPET / ergospirometry) on a treadmill. Seven-day continuous monitoring using a wearable accelerometer. Collection of a 10 mL blood sample (one EDTA tube and one serum-clotting tube), to be centrifuged and stored at -80°C in the CHU de Liège "BHUL" biobank.

    Also known as: Accelerometer Data, Biology sample, quality of life and physical activity validated evaluation forms

06

What researchers measure

Primary outcomes

  1. EKG anomaly

    Presence of arrhythmia, prolonged QTc interval, or conduction disorders.

    Time frame: At inclusion (single study visit)

  2. Echocardiography anomaly: systolic dysfunction

    Systolic dysfunction: LVEF \< 55% or a relative decrease of \>15%.

    Time frame: At inclusion (single study visit)

  3. Echocardiography anomaly: diastolic dysfunction

    Based on standardized pediatric values : * E/A ratioaverage * E/e' \> 14 * e' velocities * LA volume index \> 32 mL/m².

    Time frame: At inclusion (single study visit)

  4. Echocardiography anomaly: Significant alteration in myocardial deformation

    GLS decrease \> 15%

    Time frame: At inclusion (single study visit)

  5. Echocardiography anomaly: myocardial work indices

    abnormal Myocardial Work indices

    Time frame: At inclusion (single study visit)

  6. Echocardiography anomaly: valvular disease or heart inflammation

    Structural/Inflammatory damage: Significant valvular disease, or signs of acute/chronic pericarditis and myocarditis.

    Time frame: At inclusion (single study visit)

  7. Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity

    defined as peak VO2 \< 85% or maximal workload \< 85% of predicted theoretical values.

    Time frame: At inclusion (single study visit)

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07408362
Lead sponsor
Centre Hospitalier Universitaire de Liege
Collaborators
Centre Hospitalier Régional de la Citadelle
Responsible party
Caroline Jacquemart (Pediatrician, MD, Head of Clinic, Centre Hospitalier Universitaire de Liege) — Principal investigator
First posted
Feb 13, 2026
Start date
Feb 15, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2033 (estimated)
Last update
Feb 13, 2026

Study contacts

Caroline E M Jacquemart
Contact
caroline.jacquemart@chuliege.be
+32 4 3218451
Catherine Sondag
Contact
etudes.pediatrie@chuliege.be

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion