Hodgkin DiseaseNCT00903890
Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma
An observational study of Hodgkin Disease and Lymphoma, Non-Hodgkin, run by University of Rochester at 1 site in United States.
Trial summary
This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hodgkin Disease, Lymphoma, Non-Hodgkin
- What is being tested?
- Survey
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to 9 Apr 2020
- 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: Patients previously treated at the University of Rochester Department of Radiation Oncology.
Who may be able to join
- All patients with Hodgkin's Lymphoma and Non Hodgkin's lymphoma who underwent Radiation Therapy (RT) to either a mantle or modified mantle field with or without adriamycin at the Wilmot Cancer Center at the University of Rochester are eligible for the study.
Who cannot join
- Any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma After Radiation Therapy/Anthracycline Chemotherapy
This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.
- Conditions
- Hodgkin Disease, Lymphoma, Non-Hodgkin
- Being tested
- Survey
- Medical subject headings
- Hodgkin Disease, Lymphoma, Non-Hodgkin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SurveyOther
Survey asking questions regarding the subjects cardiac and general health.
| Study group | Role | What they receive |
|---|---|---|
| A | Individuals who have previously received radiation therapy and anthracycline chemotherapy for their Hodgkin's or non-Hodgkin's lymphoma. Receives: Other: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure changes in Cardiac ejection fraction score
Measured: Post Radiation Treatment
Measure changes in perfusion imaging score on the radionuclide cardiac profusion scan
Measured: Post Radiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2009 (estimated)
- Study startAug 2008
- Primary completionNov 2018
- Study completion9 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hodgkin DiseaseStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Louis Constine, University of Rochester
- Investigators
- Louis S Constine, MD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00903890
- Sponsor's protocol ID
- ULYM07056
- Status last verified
- Aug 2023
- First submitted
- 15 May 2009
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Effects in Long-Term Survivors of Hodgkin's and Non-Hodgkin's Lymphoma After Radiation Therapy/Anthracycline Chemotherapy
- ClinicalTrials.gov ID
- NCT00903890
- Acronym / sponsor ID
- ULYM07056
- Conditions
- Hodgkin Disease, Lymphoma, Non-Hodgkin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Nov 2018 (actual)
- Study completion
- 9 Apr 2020 (actual)
- First posted
- 19 May 2009 (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.
This study is to inquire by mailed survey regarding the cardiac and general health of patients previously treated for Hodgkin's and non-Hodgkin's lymphoma with radiation therapy/anthracycline chemotherapy.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Other: SurveyIndividuals who have previously received radiation therapy and anthracycline chemotherapy for their Hodgkin's or non-Hodgkin's lymphoma. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients previously treated at the University of Rochester Department of Radiation Oncology.
Key inclusion criteria (1 listed)
- All patients with Hodgkin's Lymphoma and Non Hodgkin's lymphoma who underwent Radiation Therapy (RT) to either a mantle or modified mantle field with or without adriamycin at the Wilmot Cancer Center at the University of Rochester are eligible for the study.
Key exclusion criteria (1 listed)
- Any severe preexisting cardiac disease (e.g., arrhythmia, angina, coronary disease, myocardial infarction, or congestive heart failure) prior to diagnosis
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 |
|---|---|---|
| SurveySurvey asking questions regarding the subjects cardiac and general health. | Other | A |
Primary outcome
Measure changes in Cardiac ejection fraction score
Time frame: Post Radiation Treatment
Measure changes in perfusion imaging score on the radionuclide cardiac profusion scan
Time frame: Post Radiation
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 14 Aug 2023.
- Individual participant dataSharing planned: No
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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.
Louis S Constine, MD principal investigator
University of Rochester
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 Disease and Lymphoma, Non-Hodgkin, run by University of Rochester 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 1 inclusion and 1 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 14 Aug 2023. 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?
Measure changes in Cardiac ejection fraction score (time frame: Post Radiation Treatment). 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 14 Aug 2023.