CardiotoxicityNCT02798679
Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
An observational study of Cardiotoxicity, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiotoxicity
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 1 Sep 2022
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive participants with breast cancer or lymphoma scheduled to receive anthracycline-based chemotherapy or trastuzumab.
Who may be able to join
- Stage I-III breast cancer or lymphoma with a >2 year life expectancy
- A treatment plan that includes anthracyclines and/or trastuzumab
- Age >45 years
- Able to hold breath for 10 seconds
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Who cannot join
- Refusal or inability to provide informed consent
- Known heart failure or LVEF <50%
- Heart rate over 100 bpm
- Renal dysfunction with GFR <30 mL/min/1.73m2
- Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
- Symptomatic claustrophobia
- Plans to move within 24 months of enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55455
About this study
The purpose of this study is to determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.
- Conditions
- Cardiotoxicity
- Medical subject headings
- Cardiotoxicity
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiotoxicity assessed clinically or by cardiac MRI
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study startAug 2016
- Primary completion1 Sep 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiotoxicityStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chetan Shenoy, MBBS, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798679
- Sponsor's protocol ID
- CV-2016-24434
- Status last verified
- Oct 2022
- First submitted
- 12 May 2016
- Last updated
- 18 Oct 2022
- 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 18 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Fibrosis and Risk Prediction in Cancer Treatment-Related Cardiotoxicity
- ClinicalTrials.gov ID
- NCT02798679
- Acronym / sponsor ID
- CV-2016-24434
- Conditions
- Cardiotoxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 14 Jun 2016 (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 determine whether pre-existing cardiac fibrosis is a predictor of cancer treatment-related cardiotoxicity.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive participants with breast cancer or lymphoma scheduled to receive anthracycline-based chemotherapy or trastuzumab.
Key inclusion criteria (5 listed)
- Stage I-III breast cancer or lymphoma with a >2 year life expectancy
- A treatment plan that includes anthracyclines and/or trastuzumab
- Age >45 years
- Able to hold breath for 10 seconds
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Key exclusion criteria (7 listed)
- Refusal or inability to provide informed consent
- Known heart failure or LVEF <50%
- Heart rate over 100 bpm
- Renal dysfunction with GFR <30 mL/min/1.73m2
- Participants with pacemakers, defibrillators, functioning neurostimulator devices or other implanted electronic devices
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiotoxicity assessed clinically or by cardiac MRI
Time frame: 24 months
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 18 Oct 2022.
- 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.
Chetan Shenoy, MBBS principal investigator
University of Minnesota
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 Cardiotoxicity, run by University of Minnesota 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 5 inclusion and 7 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 18 Oct 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?
Cardiotoxicity assessed clinically or by cardiac MRI (time frame: 24 months). 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 18 Oct 2022.