Cardiotoxicity and other Late effects After Radiotherapy and ImmunochemoTherapy in Non-Hodgkin lYmphoma

Cardiotoxicity and other Late effects After Radiotherapy and ImmunochemoTherapy in Non-Hodgkin lYmphoma - CLARITY

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON55490

Enrollment

525

Registered

2019-02-15

Start date

2020-02-18

Completion date

Unknown

Last updated

2025-09-08

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

Conditions

Non-Hodgkin lymhoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet the following criteria. Survivors: • 350 survivors of mediastinal large B-cell non-Hodgkin lymphoma (ICD-code 9679) or diffuse large B-cell non-Hodgkin lymphoma (ICD-code 9684), treated with at least five cycles of (R-)CHOP (250 mg/m2 anthracyclines or more) or treated with a combination of mediastinal radiotherapy and anthracyclines (independent of dose). o 200 survivors treated between five to thirteen years ago (2007-2015) o 150 survivors treated between thirteen to eighteen years ago (2002-2007) • The survivors were treated in one of the following centers, participating in the BETER-consortium: Amsterdam UMC (location VUmc or AMC), EMC, UMCU, UMCG, UMC Radboud or ASZ. • Age at diagnosis 15 up to 60 years. • Age at the time of inclusion: younger than 75 years old., Comparison group: • 175 siblings of the above mentioned patients with their date of birth closest to the birthdate of the survivor.

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Use of immunosuppressant and/or prednisolone • HIV-infected individuals • Pregnant women • Mental disability or psychological condition potentially hampering compliance with the study protocol • Insufficient understanding of the Dutch language

Design outcomes

Primary

Measure	Time frame
Main study parameters/endpoints: The main study parameters will be symptoms of CVD, biomarkers, echocardiographic systolic and diastolic heart parameters and global longitudinal strain measurement, electrocardiography, arterial stiffness (by pulse wave velocity measurements), endothelial function (by peripheral arterial tonometry), advanced glycation end products will be assessed by skin autofluorescence (AGE-reader). Late effects and risk factors will be assessed through questionnaires and physical measurements. Exposure to (R-)CHOP and radiotherapy will be extracted from the medical history. Multivariable logistic and linear regression analyses will be used for analyses.	—

Measure

Time frame

Main study parameters/endpoints: The main study parameters will be symptoms of CVD, biomarkers, echocardiographic systolic and diastolic heart parameters and global longitudinal strain measurement, electrocardiography, arterial stiffness (by pulse wave velocity measurements), endothelial function (by peripheral arterial tonometry), advanced glycation end products will be assessed by skin autofluorescence (AGE-reader). Late effects and risk factors will be assessed through questionnaires and physical measurements. Exposure to (R-)CHOP and radiotherapy will be extracted from the medical history. Multivariable logistic and linear regression analyses will be used for analyses.

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Secondary

Measure	Time frame
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Countries

Netherlands

Outcome results