Children's Oncology Group's 2023 blueprint for research: Hodgkin lymphoma.
Sharon M Castellino, Lisa Giulino-Roth, Paul Harker-Murray...
https://pubmed.ncbi.nlm.nih.gov/37505794Actively Recruiting
Age: 7Years +
All Genders
ID05705531
Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors
Led by Children's Oncology Group · Updated on 2026-05-05
190
Participants Needed
32
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to understand how blood cell growth patterns called therapy-related clonal hematopoiesis (t-CH) are linked to heart health or cardiovascular disease in patients who were treated for classical Hodgkin lymphoma during childhood or adolescence. It focuses on patients who received anthracycline chemotherapy and explores how these blood cell changes might predict future heart problems. The study is observational and seeks to identify patients at higher risk so they can be monitored more closely for early detection and prevention of heart complications. Participants undergo several procedures including blood sample collection, surveys, and cardiac magnetic resonance imaging (MRI). Their medical records are also reviewed, and archived blood samples may be collected if available. The study compares the presence of t-CH mutations in patients with and without signs of cardiovascular disease and evaluates various factors like radiation exposure, age, sex, and medication use to understand their impact on t-CH and heart health. During the study, participants provide blood samples and complete surveys while undergoing cardiac MRI without sedation. Researchers analyze these data along with medical records to assess blood cell mutations and heart function. The main outcome measured is the presence of therapy-related clonal hematopoiesis linked to cardiovascular disease within one year. Secondary evaluations look at changes over time and associations with clinical risk factors. The study helps monitor heart health risks after lymphoma treatment and runs until 2028.
CONDITIONS
Brief Title
A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
Who Can Participate
Age: 7Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patient must be 63; 7 years of age at the time of enrollment (age to perform an MRI without sedation).
- History of pathologically confirmed classical Hodgkin Lymphoma initially diagnosed between ages 63; 2 and < 22 years.
- Received a cumulative doxorubicin equivalent anthracycline dose of 63; 200 mg/m�b2 as part of frontline therapy.
- All systemic cancer treatment completed 63; 2 years prior to study enrollment.
- Not known to have had relapse, second malignancy, or death.
- Access to cardiac MRI at the enrolling institution and able to complete MRI without sedation.
You will not qualify if you...
- Medical contraindication to non-contrast cardiac MRI.
- Diagnosis of nodular lymphocyte-predominant Hodgkin Lymphoma.
- Received cancer therapy beyond initial Hodgkin Disease treatment.
- History of CTCAE grade 3 or higher cardiovascular disease existing before Hodgkin Lymphoma diagnosis, except resolved congenital conditions or managed chronic conditions.
- History of immunodeficiency prior to Hodgkin Lymphoma diagnosis, including primary immunodeficiency syndromes, organ transplant recipients, or systemic immunosuppressive therapy.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 1 year
Participants undergo collection of blood samples, cardiac MRI, surveys, and medical record review to assess blood cell growth patterns and heart health.
1 blood sample collection visit, 1 cardiac MRI visit, and survey completion; archived blood sample collection if available
Long-term Monitoring
Duration - Up to 1 year
Participants are observed over time to evaluate changes in clonal hematopoiesis and cardiovascular disease indicators.
Follow-up assessments as scheduled during the year
Trial Site Locations
Total: 32 locations
1
USA Health Strada Patient Care Center
Mobile, Alabama, United States, 36604
Actively Recruiting
2
Phoenix Childrens Hospital
Phoenix, Arizona, United States, 85016
Actively Recruiting
3
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010
Actively Recruiting
4
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
5
Yale University
New Haven, Connecticut, United States, 06520
Actively Recruiting
6
Alfred I duPont Hospital for Children
Wilmington, Delaware, United States, 19803
Actively Recruiting
7
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Actively Recruiting
8
Arnold Palmer Hospital for Children
Orlando, Florida, United States, 32806
Actively Recruiting
9
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, United States, 33607
Actively Recruiting
10
Children's Healthcare of Atlanta - Arthur M Blank Hospital
Atlanta, Georgia, United States, 30329
Actively Recruiting
11
Southern Illinois University School of Medicine
Springfield, Illinois, United States, 62702
Actively Recruiting
12
University of Maryland/Greenebaum Cancer Center
Baltimore, Maryland, United States, 21201
Actively Recruiting
13
C S Mott Children's Hospital
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
14
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, United States, 55404
Actively Recruiting
15
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
16
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
Actively Recruiting
17
Albany Medical Center
Albany, New York, United States, 12208
Actively Recruiting
18
Roswell Park Cancer Institute
Buffalo, New York, United States, 14263
Actively Recruiting
19
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
20
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
21
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Actively Recruiting
22
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
23
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
24
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
Actively Recruiting
25
East Tennessee Childrens Hospital
Knoxville, Tennessee, United States, 37916
Actively Recruiting
26
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Actively Recruiting
27
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
28
Children's Hospital of San Antonio
San Antonio, Texas, United States, 78207
Actively Recruiting
29
University of Virginia Cancer Center
Charlottesville, Virginia, United States, 22908
Actively Recruiting
30
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
31
University of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
32
Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Suspended
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How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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