Tissue and Functional Assessment of Myocardial Injury in Hodgkin Lymphoma (HL) Survivors
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Memorial Sloan Kettering Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Classical or nodular lymphocyte predominant HL treated at Memorial Sloan-Kettering Cancer Center.
- Age ≥ 18 years
- Treatment for HL that included mediastinal RT at initial diagnosis or relapse.
- ≥ 5 years from last HL treatment.
Exclusion Criteria:
- Primary HL diagnosis prior to 1980.
- Additional mediastinal RT or subsequent cardiotoxic systemic therapy for secondary malignant neoplasm.
- Known CAD/CHF (defined as documented myocardial infarction, cardiac revascularization, angiographic obstructive CAD, or decreased LV function [EF < 55%] during prior clinical care).
- Contraindication to MRI (i.e. pacemakers, defibrillators, or aneurysm clips, or other implanted ferromagnetic objects), gadolinium (i.e. known hypersensitivity to gadolinium, advanced renal insufficiency as defined by glomerular filtration rate <30 ml/min/1.73m^2).
- Contraindication to exercise stress testing other than the above (i.e. unstable angina or severe valvular stenosis).
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Number of groups / cohorts
Cohorts and Interventions
Group / CohortGroup / Cohort |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Hodgkin Lymphoma Survivor
This is a prospective cross-sectional study of 200 HL survivors whose treatment included mediastinal RT at initial diagnosis or relapse, and are at least 5 years from last HL treatment.
|
HL treatment will be determined by review of available medical records as archived at MSKCC.
Recorded variables will include: (1) RT - field, fractional and cumulative dose, and duration; (2) chemotherapy - regimen, planned interval, dose per cycle, and cumulative dosages.
Patients will also be asked to complete the FACT-LYM questionnaire and the FACIT Fatigue questionnaire.
Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.
Both imaging tests will be performed within a 30 day interval, with the two modalities interpreted by dedicated study investigators blinded to the results of the other modality.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
compare the prevalence of cardiac injury
Time Frame: 2 years
|
detected by cardiac MRI to that detected by stress echocardiography among a broadly representative cohort of Hodgkin lymphoma survivors.
|
2 years
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Principal Investigator: Alison Moskowitz, MD, Memorial Sloan Kettering Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Estimated)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 14-017
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.