Early Markers of Radiation-Induced Cardiac Injury in Hodg... | NCT02404818

Studies
Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy

NCT02404818

Sponsor

University of Florida

Status

Completed

Last Update Posted

Jun 10, 2022Actual

Enrollment

5Estimated

Phase

Not provided

Conditions

Hodgkin's Lymphoma

Interventions

Cardiac Magnetic Resonance Imaging
Echocardiogram

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
IRB201703302	Other Identifier	UF IRB-03

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2015

Primary Completion Date

Apr 14, 2021Actual

Completion Date

Apr 14, 2021Actual

First Submitted Date

Mar 20, 2015

First Submission Date that Met QC Criteria

Mar 26, 2015

First Posted Date

Apr 1, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 9, 2022

Last Update Posted Date

Jun 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

5Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Survivors of Hodgkin's lymphoma		Cardiac Magnetic Resonance Imaging and Echocardiogram	Procedure: Cardiac Magnetic Resonance Imaging Procedure: Echocardiogram

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cardiac Magnetic Resonance Imaging	Procedure	A cardiac MRI will be performed.	Survivors of Hodgkin's lymphoma

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cardiac Abnormalities As Measured By Cardiac MRI		Day 1
Cardiac Abnormalities As Measured By Echocardiogram		Day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
Patient must be ≥ 18 years at time of consent.

Exclusion Criteria:

Pregnant women at time of Cardiac MRI
Contraindications to Cardiac MRI (contrast allergy, metal implants, medical devices)
Glomerular filtration rate (GFR) < 30, unless approved by Radiologist (UF Health Jacksonville Radiology Policy: Administration of Gadolinium-Based Contrast Agents).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bradford S Hoppe, MD, MPH	University of Florida Health Proton Therapy Institute	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Florida Health Proton Therapy Institute		Jacksonville	Florida	32206	United States

Condition Browse Module

MeSH Terms

ID	Term
D006689	Hodgkin Disease

Ancestor Terms

ID	Term
D008223	Lymphoma
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders

Browse Leaves

Not provided

Browse Branches

Not provided