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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

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