This study assesses how blood cell growth patterns (clonal hematopoiesis) relate to heart health or cardiovascular disease (CVD) after treatment in patients with Hodgkin lymphoma. In some patients, cancer treatment at a young age may lead to later complications, including problems with heart health. Checking for blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) can help predict who might be at risk for heart health problems after Hodgkin lymphoma treatment. If doctors know who may be at greater risk for developing later heart complications, then they can more closely monitor those patients to prevent or detect heart complications early.
PRIMARY OBJECTIVES: I. To assess the prevalence of therapy-related clonal hematopoiesis (t-CH) possessing somatic mutations associated with cardiovascular disease (CVD) in anthracycline exposed pediatric classical Hodgkin Lymphoma patients detected after front line Hodgkin Lymphoma therapy. II. To compare rates of t-CH possessing somatic mutations associated with CVD between anthracycline exposed pediatric classical Hodgkin Lymphoma patients with versus without objective signs of CVD according to cardiac magnetic resonance imaging (MRI). SECONDARY OBJECTIVES: I. To evaluate whether the incidence of t-CH possessing somatic mutations associated with CVD increases over time among pediatric classical Hodgkin Lymphoma patients previously treated with anthracyclines. II. To compare rates of objective findings of CVD between groups of anthracycline exposed pediatric classical Hodgkin Lymphoma patients with versus without clinical risk factors for CVD. EXPLORATORY OBJECTIVES: I. To compare the prevalence of t-CH with mutations associated with CVD between anthracycline exposed pediatric classical Hodgkin Lymphoma patients who received versus did not receive mediastinal radiation as part of their initial treatment. II. To assess whether specific patient characteristics and other treatment components (age, sex, race, dexrazoxane usage, etc.) are associated with an increased likelihood of t-CH with mutations associated with CVD. III. To evaluate the effect of t-CH with mutations associated with CVD on objective findings of CVD, as adjusted for or mediated by other factors such as patient characteristics and clinical conditions associated with an elevated risk for CVD. OUTLINE: This is an observational study. Patients undergo collection of blood samples, complete surveys, and undergo cardiac MRI on study. Patients also have their medical records reviewed and may have archived blood samples collected if available.
Study Type
OBSERVATIONAL
Enrollment
190
Undergo collection of archived blood sample
Undergo blood sample collection
Undergo medical record abstraction
Undergo MRI
Complete surveys
USA Health Strada Patient Care Center
Mobile, Alabama, United States
RECRUITINGPhoenix Childrens Hospital
Phoenix, Arizona, United States
RECRUITINGYale University
New Haven, Connecticut, United States
RECRUITINGAlfred I duPont Hospital for Children
Wilmington, Delaware, United States
Therapy-related clonal hematopoiesis (t-CH) with mutations associated with cardiovascular disease
Measured in the blood of eligible participants who were previously treated with anthracycline-containing therapy for pediatric classical Hodgkin lymphoma.
Time frame: Up to 1 year
Expansion of CH
The outcome is the expansion of the CH, which will be expressed as the variant allele fraction (VAF) (CH verses the total normal DNA in the sample). Graphic analysis to reveal the time varying trend in the association between the expansion of CH over time and the presence/worsening of CVD signs and apply generalized estimating equation method (with each patient as cluster unit) to quantify this association while controlling for the potential correlation of repeated measurements within each patient.
Time frame: Up to 1 year
Association between the presence of CVD and individual variables
The outcome is the presence of CVD. This aim is to determine if there is an association between the presence of CVD and the individual variables constituting the clinical profile, either parametric (e.g., independent t-test, Chi\^2-test, Pearson correlation coefficients) or nonparametric (e.g., Wilcoxon rank sum tests, Spearman's rank correlation coefficients) methods will be applied. Bootstrapping techniques might be used as a method of inference which does not rely on a specific underlying distribution. The statistical significance level will be set to 0.05 and all data analysis will be done using SAS statistical software (version 9.4).
Time frame: Up to 1 year
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Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States
RECRUITINGArnold Palmer Hospital for Children
Orlando, Florida, United States
RECRUITINGSaint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States
RECRUITINGChildren's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States
RECRUITINGUniversity of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States
RECRUITINGC S Mott Children's Hospital
Ann Arbor, Michigan, United States
RECRUITING...and 19 more locations