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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)

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)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29157
Enrollment
200
Registered
2019-08-14
Start date
2018-04-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Previous history of Hodgkin or mediastinal non-Hodgkin lymphoma treated with mediastinal radiotherapy with or without anthracycline-containing chemotherapy

Interventions

None

Sponsors

Department of radiotherapy and cardiology of Erasmus MC
Lead Sponsor

Eligibility

Inclusion criteria

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

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).

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
– To describe the early symptoms of long-term cardiac toxicity induced by radiotherapy with or without chemotherapy for HL and NHL patients. – Develop a screening tool for the early detection of cardiac toxicity including biomarkers, imaging tests and PROMs. – Difference in score of the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and the Seattle Angina Questionnaire (SAQ-7). – To evaluate the value of cardiac MRI as an objective diagnostic tool for mediastinal radiotherapy and/or chemotherapy induced cardiac toxicities. – To evaluate the dose effect relationship between the detected increase in cardiac symptoms and various late severe cardiac toxicities. - 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).

Contacts

Public ContactOlivier Manintveld

Erasmus MC

o.manintveld@erasmusmc.nl01070350478

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)