Trial Title:
A Study About How Blood Cell Growth Patterns Relate to Heart Health After Treatment for Hodgkin Lymphoma
NCT ID:
NCT05705531
Condition:
Cardiovascular Disorder
Clonal Hematopoiesis
Hodgkin Lymphoma
Conditions: Official terms:
Lymphoma
Hodgkin Disease
Cardiovascular Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood specimen collection
Arm group label:
Observational (blood samples, surveys, MRI, record review)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Health Record Review
Description:
Undergo medical record abstraction
Arm group label:
Observational (blood samples, surveys, MRI, record review)
Intervention type:
Procedure
Intervention name:
Magnetic Resonance Imaging
Description:
Undergo MRI
Arm group label:
Observational (blood samples, surveys, MRI, record review)
Other name:
Magnetic Resonance
Other name:
Magnetic Resonance Imaging (MRI)
Other name:
Magnetic resonance imaging (procedure)
Other name:
Magnetic Resonance Imaging Scan
Other name:
Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
Other name:
MR
Other name:
MR Imaging
Other name:
MRI
Other name:
MRI Scan
Other name:
MRIs
Other name:
NMR Imaging
Other name:
NMRI
Other name:
Nuclear Magnetic Resonance Imaging
Other name:
sMRI
Other name:
Structural MRI
Intervention type:
Other
Intervention name:
Survey Administration
Description:
Complete surveys
Arm group label:
Observational (blood samples, surveys, MRI, record review)
Summary:
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.
Detailed description:
PRIMARY OBJECTIVES:
I. To assess the prevalence of participants in AHOD1331 with therapy-related clonal
hematopoiesis (t-CH) possessing somatic mutations associated with cardiovascular disease
(CVD) which are detected after Hodgkin Lymphoma therapy.
II. To assess participants of AHOD1331 with t-CH for the presence or absence of objective
signs of CVD using cardiac magnetic resonance imaging (MRI).
SECONDARY OBJECTIVES:
I. To assess whether participants in AHOD1331 with t-CH expand this population over time
and possess objective findings of CVD.
II. To assess whether patients both with and without objective findings of CVD using
cardiac MRI possess clinical risk factors for CVD.
EXPLORATORY OBJECTIVES:
I. To assess the prevalence of patients receiving mediastinal radiation who have
objective findings of CVD using cardiac MRI, that also possess t-CH with mutations
associated with CVD.
II. To assess whether specific patient characteristics and treatment (age, gender, race,
dexrazoxane usage, etc.) correlate with a higher incidence of t-CH with mutations
associated with CVD.
III. To assess the effects of t-CH on CVD by considering 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.
Criteria for eligibility:
Study pop:
Prior to enrollment on this study, patients must have been enrolled on AHOD1331.
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- Patient must be >= 7 years of age at the time of enrollment (age to perform an MRI
without sedation).
- Enrolled and completed therapy on AHOD1331.
- 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.
- Patient must have access to cardiac MRI at institution where receiving follow-up
care and must be able to complete cardiac MRI without sedation.
- All patients and/or their parents or legal guardians must sign a written informed
consent.
- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met
Exclusion Criteria:
- Medical contraindication to undergoing a cardiac MRI.
- Removed from AHOD1331 therapy prior to completing the AHOD1331 protocol specified
treatment plan.
- Received cancer therapy in addition to that of AHOD1331 (e.g., for disease
progression or recurrence, or subsequent malignant neoplasm).
- History of cardiovascular disease prior to enrollment on AHOD1331.
Gender:
All
Minimum age:
7 Years
Maximum age:
40 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
USA Health Strada Patient Care Center
Address:
City:
Mobile
Zip:
36604
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-388-8721
Investigator:
Last name:
Hamayun Imran
Email:
Principal Investigator
Facility:
Name:
Phoenix Childrens Hospital
Address:
City:
Phoenix
Zip:
85016
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
602-546-0920
Investigator:
Last name:
Alexandra M. Walsh
Email:
Principal Investigator
Facility:
Name:
Alfred I duPont Hospital for Children
Address:
City:
Wilmington
Zip:
19803
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
302-651-5572
Email:
Allison.bruce@nemours.org
Investigator:
Last name:
Emi H. Caywood
Email:
Principal Investigator
Facility:
Name:
Golisano Children's Hospital of Southwest Florida
Address:
City:
Fort Myers
Zip:
33908
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
239-343-5333
Email:
molly.arnstrom@leehealth.org
Investigator:
Last name:
Emad K. Salman
Email:
Principal Investigator
Facility:
Name:
Saint Joseph's Hospital/Children's Hospital-Tampa
Address:
City:
Tampa
Zip:
33607
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
813-357-0849
Email:
jennifer.manns@baycare.org
Investigator:
Last name:
Don E. Eslin
Email:
Principal Investigator
Facility:
Name:
C S Mott Children's Hospital
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-865-1125
Investigator:
Last name:
Emily B. Walling
Email:
Principal Investigator
Facility:
Name:
Children's Hospitals and Clinics of Minnesota - Minneapolis
Address:
City:
Minneapolis
Zip:
55404
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
612-813-5913
Email:
pauline.mitby@childrensmn.org
Investigator:
Last name:
Michael K. Richards
Email:
Principal Investigator
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-600-3606
Email:
info@siteman.wustl.edu
Investigator:
Last name:
Robert J. Hayashi
Email:
Principal Investigator
Facility:
Name:
Hackensack University Medical Center
Address:
City:
Hackensack
Zip:
07601
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
551-996-2897
Investigator:
Last name:
Katharine R. Lange
Email:
Principal Investigator
Facility:
Name:
Albany Medical Center
Address:
City:
Albany
Zip:
12208
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
518-262-5513
Investigator:
Last name:
Lauren R. Weintraub
Email:
Principal Investigator
Facility:
Name:
Roswell Park Cancer Institute
Address:
City:
Buffalo
Zip:
14263
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
800-767-9355
Email:
askroswell@roswellpark.org
Investigator:
Last name:
Kara M. Kelly
Email:
Principal Investigator
Facility:
Name:
Cincinnati Children's Hospital Medical Center
Address:
City:
Cincinnati
Zip:
45229
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
513-636-2799
Email:
cancer@cchmc.org
Investigator:
Last name:
Jonathan D. Bender
Email:
Principal Investigator
Facility:
Name:
Nationwide Children's Hospital
Address:
City:
Columbus
Zip:
43205
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
614-722-6039
Email:
Melinda.Triplet@nationwidechildrens.org
Investigator:
Last name:
Mark A. Ranalli
Email:
Principal Investigator
Facility:
Name:
Oregon Health and Science University
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
503-494-1080
Email:
trials@ohsu.edu
Investigator:
Last name:
Susan J. Lindemulder
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Philadelphia
Address:
City:
Philadelphia
Zip:
19104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
267-425-5544
Email:
CancerTrials@email.chop.edu
Investigator:
Last name:
Jill P. Ginsberg
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of Pittsburgh of UPMC
Address:
City:
Pittsburgh
Zip:
15224
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
412-692-8570
Email:
jean.tersak@chp.edu
Investigator:
Last name:
Jean M. Tersak
Email:
Principal Investigator
Facility:
Name:
Cook Children's Medical Center
Address:
City:
Fort Worth
Zip:
76104
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
682-885-2103
Email:
CookChildrensResearch@cookchildrens.org
Investigator:
Last name:
Donald T. Beam
Email:
Principal Investigator
Facility:
Name:
Children's Hospital of San Antonio
Address:
City:
San Antonio
Zip:
78207
Country:
United States
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
210-704-2894
Email:
bridget.medina@christushealth.org
Investigator:
Last name:
Julie Voeller
Email:
Principal Investigator
Facility:
Name:
Hospital for Sick Children
Address:
City:
Toronto
Zip:
M5G 1X8
Country:
Canada
Status:
Recruiting
Contact:
Last name:
Site Public Contact
Phone:
416-813-7654
Email:
ask.CRS@sickkids.ca
Investigator:
Last name:
Angela S. Punnett
Email:
Principal Investigator
Start date:
August 18, 2023
Completion date:
October 1, 2028
Lead sponsor:
Agency:
Children's Oncology Group
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Source:
Children's Oncology Group
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05705531
