NCT05705531 A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
| NCT ID | NCT05705531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Oncology Group |
| Condition | Cardiovascular Disorder |
| Study Type | OBSERVATIONAL |
| Enrollment | 190 participants |
| Start Date | 2023-08-18 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 190 participants in total. It began in 2023-08-18 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation). * History of pathologically confirmed classical Hodgkin Lymphoma (cHL) initially diagnosed when the patient was \>= 2 and \< 22 years of age. * As part of frontline therapy for cHL, the patient must have received a cumulative doxorubicin equivalent anthracycline dose of ≥ 200 mg/m\^2 as estimated in doxorubicin isotoxic equivalents dose conversion calculation. * Note: History of COG therapeutic trial participation is not required. Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used as reference documentation of receipt of anthracycline dose. * All systemic cancer treatment must have been completed ≥ 2 years prior to study enrollment. * Not known to have had a primary event (relapse/second malignancy/death). * Note: Subjects treated at another institution are eligible if they are now being followed at the current COG institution, if the study procedures can be performed and the data accessible by a COG institution where the study is open. * Patient must have access to cardiac MRI at the enrolling institution and must be able to complete cardiac MRI without sedation. Exclusion Criteria: * Medical contraindication to undergoing a non-contrast cardiac MRI. * Patients with nodular lymphocyte-predominant HL. * Received cancer therapy in addition to that for primary Hodgkin Disease (e.g., for disease progression or recurrence, or subsequent malignant neoplasm). * History of CTCAE grade 3 or higher cardiovascular disease or condition known to exist prior to the patient's initial diagnosis of cHL. * Note: exceptions are made for congenital conditions considered fully resolved by surgery and chronic conditions such as hypertension or hypercholesterolemia that are managed with medical intervention. * History of an immunodeficiency that existed prior to cHL diagnosis, such as primary immunodeficiency syndromes, organ transplant recipients and conditions requiring systemic immunosuppressive agents.
Contact & Investigator
Robert J Hayashi
PRINCIPAL INVESTIGATOR
Children's Oncology Group
Frequently Asked Questions
Who can join the NCT05705531 clinical trial?
This trial is open to participants of all sexes, aged 7 Years or older, studying Cardiovascular Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05705531 currently recruiting?
Yes, NCT05705531 is actively recruiting participants. Visit ClinicalTrials.gov or contact Children's Oncology Group to inquire about joining.
Where is the NCT05705531 trial being conducted?
This trial is being conducted at Mobile, United States, Phoenix, United States, Duarte, United States, Madera, United States and 11 additional locations.
Who is sponsoring the NCT05705531 clinical trial?
NCT05705531 is sponsored by Children's Oncology Group. The principal investigator is Robert J Hayashi at Children's Oncology Group. The trial plans to enroll 190 participants.