Cardiomyopathy and heart failure risk after treatment for Hodgkin lymphoma or aggressive B cell non-Hodgkin lymphoma

Cardiomyopathy and heart failure risk after treatment for Hodgkin lymphoma or aggressive B cell non-Hodgkin lymphoma - CRYSTAL case-control

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50135

Enrollment

800

Registered

2020-01-16

Start date

2020-01-31

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

cardiomyopathy Heartfailure

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: All lymphoma survivors who meet the inclusion criteria of the P11CHT study or the CRYSTAL cohort study are eligible for the CRYSTAL case-control study. The most important inclusion criteria for the P11CHT and CRYSTAL cohort study are: * Diagnosis of Hodgkin's lymphoma (P11CHT) or aggressive B-cell non-Hodgkin's lymphoma (CRYSTAL cohort) * Treatment for the lymphoma between 1965 and 2005 (P11CHT) or between 1989 and 2012 (CRYSTAL cohort) * Age at diagnosis

Exclusion criteria

Exclusion criteria: * A history of (symptomatic) myocardial infarction, valvular heart disease, cardiomyopathy or heart failure before lymphoma diagnosis * Chemotherapy or immunotherapy for a primary malignancy before lymphoma diagnosis * Radiotherapy to the trunk before lymphoma diagnosis * Myocardial infarction or *CTCAE grade 2 valvular heart disease prior to diagnosis of cardiomyopathy or heart failure * Insufficient understanding of the Dutch language (for survivors receiving the questionnaire)

Design outcomes

Primary

Measure	Time frame
Cardiomyopathy and congestive heart failure will be graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Treatment histories of cases and controls will be compared using conditional logistic regression models. We will specifically focus on exposure distributions, cumulative drug dose for each cytostatic drug used (specifically doxorubicin, cyclophosphamide and rituximab) and mediastinal irradiation. The effect of cardiovascular risk factors such as hypertension, hypercholesterolemia, diabetes mellitus type II, smoking and family history of cardiovascular diseases will also be evaluated. Radiation charts and simulation radiographs will be used to estimate mean heart dose (MHD) and the radiation dose-response relationship will be modelled. Blood samples will be used for examination of susceptibility genes for anthracycline and/or radiation induced CVDs.	—

Measure

Time frame

Cardiomyopathy and congestive heart failure will be graded according to the Common Terminology Criteria for Adverse Events, version 4.0. Treatment histories of cases and controls will be compared using conditional logistic regression models. We will specifically focus on exposure distributions, cumulative drug dose for each cytostatic drug used (specifically doxorubicin, cyclophosphamide and rituximab) and mediastinal irradiation. The effect of cardiovascular risk factors such as hypertension, hypercholesterolemia, diabetes mellitus type II, smoking and family history of cardiovascular diseases will also be evaluated. Radiation charts and simulation radiographs will be used to estimate mean heart dose (MHD) and the radiation dose-response relationship will be modelled. Blood samples will be used for examination of susceptibility genes for anthracycline and/or radiation induced CVDs.

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Countries

Netherlands

Outcome results