A PROspective, explorative cohort study to correlate CARdiac BIomarkers with late cardiac toxicity induced by radiotherapy alone or combined with anthracycline chemotherapy for hodgkin lymphoma (PROCARBI)
- Conditions
- 1008220610003216Cardiotoxicity and cardiovascular disease
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
To be eligible participating in this study, patients must meet all the following criteria:
* Previous history of Hodgkin or mediastinal non-Hodgkin lymphoma treated with mediastinal radiotherapy with or without anthracycline-containing chemotherapy
* Planned visit at the BETER clinic
* Written informed consent
* Age ><= 18 years
* With a minimum of 5 years of disease free survival
Exclusion Criteria
4.3 * Exclusion criteria;Not currently under treatment for malignant disease (unless basal cell carcinoma)
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Main study parameter/endpoint<br /><br>The main study parameter is the blood concentrations of a panel of biomarkers<br /><br>of cardiac toxicity including NT-proBNP, ST2, GDF15, Galectin 3, hsTn.<br /><br>The main studied endpoint is an increase in cardiac symptoms, as observed with<br /><br>standard evaluation at the BETER poli and scores on the PROMs. This is the<br /><br>case, if one of the following occurs:<br /><br>- KCCQ: a mean difference over time of 5 points on the KCCQ Overall Summary<br /><br>Scale reflects a clinically significant change in heart failure status.<br /><br>- SAQ-7: A change in one of the scales of at least 10 points is the minimum<br /><br>clinically relevant change.<br /><br>- Anamnesis: the physician at the BETER clinic concludes a change in heart<br /><br>failure related symptoms at the second visit compared to the visit of<br /><br>inclusion.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary study parameters/endpoints<br /><br>* Changes on MRI, indicating possible early cardiac damage.<br /><br>* Changes on the ECG.<br /><br>* Scores on the individual PROMs (with the validated KCCQ: heart failure, with<br /><br>the validated SAQ-7: coronary artery disease).<br /><br>* General health status as measured with the validated EQ-5D.<br /><br>* Late cardiac clinical toxicities (observed during the entire follow-up at the<br /><br>BETER poli).<br /><br>* Presence of deviations observed on the MRI of Visit 2 that were not present<br /><br>at Visit 1</p><br>