Cancer Therapy-related Cardiovascular ToxicityCTRCT-pediaNCT07408362
Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Cancer Therapies
A study testing Ergospirometry in people with Cancer Therapy-related Cardiovascular Toxicity and Childhood Cancer, run by Centre Hospitalier Universitaire de Liege.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 25 years
- Conditions the study is for
- Cancer Therapy-related Cardiovascular Toxicity, Childhood Cancer, Chemotherapeutic Toxicity
- What is being tested?
- Ergospirometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 15 Feb 2026to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Active disease recurrence or relapse.
- Current administration of antineoplastic therapy.
- Withdrawal of consent or refusal to participate by the patient or their legal representatives.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Catherine Sondag contact
About this study
Official title: How to Improve Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Chemotherapy and/or Thoracic Radiotherapy? Multimodal Cardiological Evaluation and Biomarkers.
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?
Read more
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.
- Conditions
- Cancer Therapy-related Cardiovascular Toxicity, Childhood Cancer, Chemotherapeutic Toxicity, Radiotherapy Side Effect, Cardiovascular Complication
- Being tested
- Ergospirometry
- Medical subject headings
- Neoplasms, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErgospirometryDiagnostic test
Also called Accelerometer Data, Biology sample, quality of life and physical activity validated evaluation forms
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.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Cancer Survivors in CHU Liege | Experimental | 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. Receives: Diagnostic Test: Ergospirometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
EKG anomaly
Presence of arrhythmia, prolonged QTc interval, or conduction disorders.
Measured: At inclusion (single study visit)
Echocardiography anomaly: systolic dysfunction
Systolic dysfunction: LVEF < 55% or a relative decrease of >15%.
Measured: At inclusion (single study visit)
Echocardiography anomaly: diastolic dysfunction
Based on standardized pediatric values :
- E/A ratioaverage
- E/e' > 14
- e' velocities
- LA volume index > 32 mL/m².
Measured: At inclusion (single study visit)
Echocardiography anomaly: Significant alteration in myocardial deformation
GLS decrease > 15%
Measured: At inclusion (single study visit)
Echocardiography anomaly: myocardial work indices
abnormal Myocardial Work indices
Measured: At inclusion (single study visit)
Echocardiography anomaly: valvular disease or heart inflammation
Structural/Inflammatory damage: Significant valvular disease, or signs of acute/chronic pericarditis and myocarditis.
Measured: At inclusion (single study visit)
Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity
defined as peak VO2 < 85% or maximal workload < 85% of predicted theoretical values.
Measured: At inclusion (single study visit)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start15 Feb 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer Therapy-related Cardiovascular ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Liege
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle
- Responsible party
- Principal investigator, Caroline Jacquemart, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07408362
- Sponsor's protocol ID
- B7072025000104
- Acronym
- CTRCT-pedia
- Status last verified
- Feb 2026
- First submitted
- 27 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How to Improve Early Diagnosis and Cardiovascular Risk Stratification in Children Exposed to Chemotherapy and/or Thoracic Radiotherapy? Multimodal Cardiological Evaluation and Biomarkers.
- ClinicalTrials.gov ID
- NCT07408362
- Acronym / sponsor ID
- CTRCT-pedia / B7072025000104
- Conditions
- Cancer Therapy-related Cardiovascular Toxicity, Childhood Cancer, Chemotherapeutic Toxicity, Radiotherapy Side Effect, Cardiovascular Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de LiegeUniversity, hospital or other
- Collaborators
- Centre Hospitalier Régional de la Citadelle
- Study start
- 15 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 13 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric Cancer Survivors in CHU Liege | Experimental | Diagnostic Test: ErgospirometryPatients 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. |
Who may qualify
- Ages
- 2 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- Active disease recurrence or relapse.
- Current administration of antineoplastic therapy.
- Withdrawal of consent or refusal to participate by the patient or their legal representatives.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ErgospirometryAlso: Accelerometer Data, Biology sample, quality of life and physical activity validated evaluation formsCompletion 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. | Diagnostic test | Pediatric Cancer Survivors in CHU Liege |
Primary outcome
EKG anomaly
Time frame: At inclusion (single study visit)
Presence of arrhythmia, prolonged QTc interval, or conduction disorders.
Echocardiography anomaly: systolic dysfunction
Time frame: At inclusion (single study visit)
Systolic dysfunction: LVEF < 55% or a relative decrease of >15%.
Echocardiography anomaly: diastolic dysfunction
Time frame: At inclusion (single study visit)
Based on standardized pediatric values : * E/A ratioaverage * E/e' > 14 * e' velocities * LA volume index > 32 mL/m².
Echocardiography anomaly: Significant alteration in myocardial deformation
Time frame: At inclusion (single study visit)
GLS decrease > 15%
Echocardiography anomaly: myocardial work indices
Time frame: At inclusion (single study visit)
abnormal Myocardial Work indices
Echocardiography anomaly: valvular disease or heart inflammation
Time frame: At inclusion (single study visit)
Structural/Inflammatory damage: Significant valvular disease, or signs of acute/chronic pericarditis and myocarditis.
Cardiopulmonary Exercise Testing (CPET): Impaired functional capacity
Time frame: At inclusion (single study visit)
defined as peak VO2 < 85% or maximal workload < 85% of predicted theoretical values.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Catherine Sondag contact
Questions about this trial
What is this clinical trial studying?
A study testing Ergospirometry in people with Cancer Therapy-related Cardiovascular Toxicity and Childhood Cancer, run by Centre Hospitalier Universitaire de Liege.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Caroline E M Jacquemart (+32 4 3218451, caroline.jacquemart@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EKG anomaly (time frame: At inclusion (single study visit)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.