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)
Recruiting
- Conditions
- Previous history of Hodgkin or mediastinal non-Hodgkin lymphoma treated with mediastinal radiotherapy with or without anthracycline-containing chemotherapy
- Registration Number
- NL-OMON29157
- Lead Sponsor
- Department of radiotherapy and cardiology of Erasmus MC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion 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
• A minimum of 5 years of disease free survival
Exclusion Criteria
• Not currently under treatment for malignant disease (unless basal cell carcinoma).
• Patients who already underwent a surgical intervention for cardiac problems, such as heart valve replacement or a coronary artery bypass grafting (CABG).
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to evaluate in terms of sensitivity, specificity and predictive value a panel of cardiac biomarkers for the early detection of an increase in cardiac symptoms for HL and (selected) NHL long-term survivors. The panel of biomarkers will be compared to an evaluation including clinical assessment, ECG, heart US and PROMs.
- Secondary Outcome Measures
Name Time Method – To describe the early symptoms of long-term cardiac toxicity induced by radiotherapy with or without chemotherapy for HL and NHL patients.<br>– Develop a screening tool for the early detection of cardiac toxicity including biomarkers, imaging tests and PROMs.<br>– Difference in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the Seattle Angina Questionnaire (SAQ-7).<br>– To evaluate the value of cardiac MRI as an objective diagnostic tool for mediastinal radiotherapy and/or chemotherapy induced cardiac toxicities.<br>– To evaluate the dose effect relationship between the detected increase in cardiac symptoms and various late severe cardiac toxicities.<br>- Evaluation of the radiation with/without anthracycline dose effect relationship, and the impact of other factors of risk (age at treatment, gender, body mass index (BMI), hypertension, diabetes, dyslipidaemia, and tobacco use).