RECRUITING

A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma

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Conditions

Cardiovascular DisorderClonal HematopoiesisHodgkin Lymphoma

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study assesses how blood cell growth patterns (clonal hematopoiesis), relates 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.

Official Title

Assessment of Clonal Hematopoiesis and Its Relationship to Cardiovascular Disease in Hodgkin Lymphoma Survivors

Quick Facts

Study Start:2023-08-18
Study Completion:2028-10-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05705531

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Years to 40 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient must be \>= 7 years of age at the time of enrollment (age to perform an MRI without sedation).
  2. * Enrolled and completed therapy on AHOD1331.
  3. * Not known to have had a primary event (relapse/second malignancy/death). Note: Subjects enrolled and/or treated on AHOD1331 at another institution are eligible if they are now being followed at the current Children's Oncology Group (COG) institution.
  4. * Patient must have access to cardiac MRI at institution where receiving follow-up care and must be able to complete cardiac MRI without sedation.
  5. * All patients and/or their parents or legal guardians must sign a written informed consent.
  6. * All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met
  1. * Medical contraindication to undergoing a cardiac MRI.
  2. * Removed from AHOD1331 therapy prior to completing the AHOD1331 protocol specified treatment plan.
  3. * Received cancer therapy in addition to that of AHOD1331 (e.g., for disease progression or recurrence, or subsequent malignant neoplasm).
  4. * History of cardiovascular disease prior to enrollment on AHOD1331.

Contacts and Locations

Principal Investigator

Robert J Hayashi
PRINCIPAL_INVESTIGATOR
Children's Oncology Group

Study Locations (Sites)

USA Health Strada Patient Care Center
Mobile, Alabama, 36604
United States
Phoenix Childrens Hospital
Phoenix, Arizona, 85016
United States
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
United States
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
United States
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
United States
C S Mott Children's Hospital
Ann Arbor, Michigan, 48109
United States
Children's Hospitals and Clinics of Minnesota - Minneapolis
Minneapolis, Minnesota, 55404
United States
Washington University School of Medicine
Saint Louis, Missouri, 63110
United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601
United States
Albany Medical Center
Albany, New York, 12208
United States
Roswell Park Cancer Institute
Buffalo, New York, 14263
United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States
Nationwide Children's Hospital
Columbus, Ohio, 43205
United States
Oregon Health and Science University
Portland, Oregon, 97239
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
United States
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, 15224
United States
East Tennessee Childrens Hospital
Knoxville, Tennessee, 37916
United States
Cook Children's Medical Center
Fort Worth, Texas, 76104
United States
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Houston, Texas, 77030
United States
Children's Hospital of San Antonio
San Antonio, Texas, 78207
United States

Collaborators and Investigators

Sponsor: Children's Oncology Group

  • Robert J Hayashi, PRINCIPAL_INVESTIGATOR, Children's Oncology Group

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-08-18
Study Completion Date2028-10-01

Study Record Updates

Study Start Date2023-08-18
Study Completion Date2028-10-01

Terms related to this study

Additional Relevant MeSH Terms

  • Cardiovascular Disorder
  • Clonal Hematopoiesis
  • Hodgkin Lymphoma