Hodgkin's LymphomaNCT02404818
Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Treated With Radiation Therapy
An observational study of Hodgkin's Lymphoma, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin's Lymphoma
- What is being tested?
- Cardiac Magnetic Resonance Imaging and Echocardiogram
- Type of treatment
- Surgery or procedure
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 14 Apr 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.
Who may be able to join
- Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
- Patient must be ≥ 18 years at time of consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
Official title: UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation
The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.
- Conditions
- Hodgkin's Lymphoma
- Being tested
- Cardiac Magnetic Resonance Imaging, Echocardiogram
- Keywords
- Radiation, Cardiac, Hodgkin's lymphoma
- Medical subject headings
- Hodgkin Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac Magnetic Resonance ImagingProcedure or surgery
A cardiac MRI will be performed.
EchocardiogramProcedure or surgery
An echocardiogram will be performed for the following information: M-mode, two-dimensional, Doppler blood flow measurements, and longitudinal strain and strain rate imaging
| Study group | Role | What they receive |
|---|---|---|
| Survivors of Hodgkin's lymphoma | Cardiac Magnetic Resonance Imaging and Echocardiogram Receives: Procedure: Cardiac Magnetic Resonance Imaging; Procedure: Echocardiogram |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac Abnormalities As Measured By Cardiac MRI
Measured: Day 1
Cardiac Abnormalities As Measured By Echocardiogram
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2015 (estimated)
- Study startApr 2015
- Primary completion14 Apr 2021
- Study completion14 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bradford S Hoppe, MD, MPH, Principal investigator, University of Florida Health Proton Therapy Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404818
- Sponsor's protocol ID
- UFPTI-1431-HL02
- Other IDs
- IRB201703302
- Status last verified
- Jun 2022
- First submitted
- 20 Mar 2015
- Last updated
- 10 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UFPTI 1431 - HL02: Investigating Early Markers of Radiation-Induced Cardiac Injury in Hodgkin Lymphoma Survivors Treated With Either Photon or Proton Radiation
- ClinicalTrials.gov ID
- NCT02404818
- Acronym / sponsor ID
- UFPTI-1431-HL02
- Conditions
- Hodgkin's Lymphoma
- Keywords
- Radiation, Cardiac, Hodgkin's lymphoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- 14 Apr 2021 (actual)
- Study completion
- 14 Apr 2021 (actual)
- First posted
- 1 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate if radiation and chemotherapy treatment cause cardiac abnormalities among survivors of Hodgkin's lymphoma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Survivors of Hodgkin's lymphoma | – | Procedure: Cardiac Magnetic Resonance Imaging, Procedure: EchocardiogramCardiac Magnetic Resonance Imaging and Echocardiogram |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hodgkin's lyphoma survivors that have received radiation at UF Health Proton Therapy Institute and also received chemotherapy.
Key inclusion criteria (2 listed)
- Completed radiation and chemotherapy treatment for Hodgkin lymphoma involving the mediastinum.
- Patient must be ≥ 18 years at time of consent.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiac Magnetic Resonance ImagingA cardiac MRI will be performed. | Procedure or surgery | Survivors of Hodgkin's lymphoma |
| EchocardiogramAn echocardiogram will be performed for the following information: M-mode, two-dimensional, Doppler blood flow measurements, and longitudinal strain and strain rate imaging | Procedure or surgery | Survivors of Hodgkin's lymphoma |
Primary outcome
Cardiac Abnormalities As Measured By Cardiac MRI
Time frame: Day 1
Cardiac Abnormalities As Measured By Echocardiogram
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bradford S Hoppe, MD, MPH principal investigator
University of Florida Health Proton Therapy Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hodgkin's Lymphoma, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac Abnormalities As Measured By Cardiac MRI (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2022.