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) - PROCARBI

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46393

Enrollment

200

Registered

2017-11-16

Start date

2017-11-01

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Cardiotoxicity and cardiovascular disease

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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 >

Exclusion criteria

Exclusion criteria: 4.3 * Exclusion criteria;Not currently under treatment for malignant disease (unless basal cell carcinoma)

Design outcomes

Primary

Measure	Time frame
Main study parameter/endpoint The main study parameter is the blood concentrations of a panel of biomarkers of cardiac toxicity including NT-proBNP, ST2, GDF15, Galectin 3, hsTn. The main studied endpoint is an increase in cardiac symptoms, as observed with standard evaluation at the BETER poli and scores on the PROMs. This is the case, if one of the following occurs: - KCCQ: a mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. - SAQ-7: A change in one of the scales of at least 10 points is the minimum clinically relevant change. - Anamnesis: the physician at the BETER clinic concludes a change in heart failure related symptoms at the second visit compared to the visit of inclusion.	—

Measure

Time frame

Main study parameter/endpoint The main study parameter is the blood concentrations of a panel of biomarkers of cardiac toxicity including NT-proBNP, ST2, GDF15, Galectin 3, hsTn. The main studied endpoint is an increase in cardiac symptoms, as observed with standard evaluation at the BETER poli and scores on the PROMs. This is the case, if one of the following occurs: - KCCQ: a mean difference over time of 5 points on the KCCQ Overall Summary Scale reflects a clinically significant change in heart failure status. - SAQ-7: A change in one of the scales of at least 10 points is the minimum clinically relevant change. - Anamnesis: the physician at the BETER clinic concludes a change in heart failure related symptoms at the second visit compared to the visit of inclusion.

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Secondary

Measure	Time frame
Secondary study parameters/endpoints * Changes on MRI, indicating possible early cardiac damage. * Changes on the ECG. * Scores on the individual PROMs (with the validated KCCQ: heart failure, with the validated SAQ-7: coronary artery disease). * General health status as measured with the validated EQ-5D. * Late cardiac clinical toxicities (observed during the entire follow-up at the BETER poli). * Presence of deviations observed on the MRI of Visit 2 that were not present at Visit 1	—

Measure

Time frame

Secondary study parameters/endpoints * Changes on MRI, indicating possible early cardiac damage. * Changes on the ECG. * Scores on the individual PROMs (with the validated KCCQ: heart failure, with the validated SAQ-7: coronary artery disease). * General health status as measured with the validated EQ-5D. * Late cardiac clinical toxicities (observed during the entire follow-up at the BETER poli). * Presence of deviations observed on the MRI of Visit 2 that were not present at Visit 1

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Countries

Netherlands

Outcome results