Hematopoietic and Lymphatic System NeoplasmNCT06353191
Biomarkers to Predict Cancer Therapy-related Cardiotoxicity
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 4 sites in United States.
Trial summary
This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematopoietic and Lymphatic System Neoplasm, Malignant Solid Neoplasm
- What is being tested?
- Non-Interventional Study
- How many people
- 693 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 May 2019to 31 Dec 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 who were treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
Who may be able to join
- 18 years of age or older
- Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
- One of the following:
- Diagnosed with cardiotoxicity defined as; cardiomyopathy, symptomatic heart failure, asymptomatic reduced systolic function, acute coronary syndrome, myocardial infarction, critical limb ischemia, cardiac arrhythmias or myocarditis possibly related to prior cancer treatment
- Completed chemotherapy with no cardiotoxicity at least two years post treatment
- Patients with cancer who will be initiating systemic therapy with potentially cardiotoxic medications. This will include chemotherapy, immunotherapy, targeted therapy that have been associated with cardiac toxicity
- An understanding of the protocol and its requirements, risks, and discomforts
- The ability and willingness to sign an informed consent
Who cannot join
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 3 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Pamela Williamson, 904-953-4694, Williamson.Pamela@mayo.edu
- Suspended
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
- Recruiting
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
Clinical Trials Referral Office, 855-776-0015, mayocliniccancerstudies@mayo.edu
Myrah Manuel, 480-574-3157, Manuel.Myrah@mayo.edu
- Recruiting
Moffitt Cancer Center
Tampa, Florida, 33612
Aixa Soyano, MD, 813-745-8268, aixa.soyano@Moffitt.org
Aixa Soyano, MD
About this study
Official title: Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity
This study evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.
Read the detailed description
PRIMARY OBJECTIVE:
- To collect biospecimens from 1) patients who developed chemotherapy related cardiac toxicity (CRCT) and 2) patients who are at a high risk for developing CRCT.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study.
- Being tested
- Non-Interventional Study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Interventional StudyOther
Non-interventional study
| Study group | Role | What they receive |
|---|---|---|
| Observational | Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study. Receives: Other: Non-Interventional Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT
Assessed by the number of participants who participate and consent to have their specimen (blood draw) retained for future research.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start3 May 2019
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic and Lymphatic System NeoplasmStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- 693 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- Nadine Norton, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353191
- Sponsor's protocol ID
- 19-002566
- Other IDs
- R01HL169268, R56HL160643, NCI-2024-00943
- Status last verified
- Aug 2026
- First submitted
- 3 Apr 2024
- Last updated
- 18 Aug 2026
- 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers to Predict Cancer Therapy-Related Cardiotoxicity
- ClinicalTrials.gov ID
- NCT06353191
- Acronym / sponsor ID
- 19-002566
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 693 participants (estimated)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 3 May 2019 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 8 Apr 2024 (actual)
- 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 evaluates why some cancer patients but not others experience changes in heart function following treatment with chemotherapy.
Detailed description
PRIMARY OBJECTIVE:
- To collect biospecimens from 1) patients who developed chemotherapy related cardiac toxicity (CRCT) and 2) patients who are at a high risk for developing CRCT.
OUTLINE: This is an observational study.
Patients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational | – | Other: Non-Interventional StudyPatients undergo blood sample collection and have their medical records reviewed on study. Patients may also optionally undergo ECG on study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who were treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
Key inclusion criteria (8 listed)
- 18 years of age or older
- Treated for any malignancy with any type of chemotherapy including oral, parenteral therapy and immunotherapy
- One of the following:
- An understanding of the protocol and its requirements, risks, and discomforts
- The ability and willingness to sign an informed consent
Key exclusion criteria (1 listed)
- Inability on the part of the patient to understand the informed consent or be compliant with the protocol
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 |
|---|---|---|
| Non-Interventional StudyNon-interventional study | Other | Observational |
Primary outcome
Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT
Time frame: Baseline
Assessed by the number of participants who participate and consent to have their specimen (blood draw) retained for future research.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
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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.
Nadine Norton, PhD principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematopoietic and Lymphatic System Neoplasm and Malignant Solid Neoplasm, run by Mayo Clinic at 4 sites 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 8 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: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Referral Office (855-776-0015, mayocliniccancerstudies@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collection of biospecimens from patients who developed cardiac toxicity (CRCT) or who are at high risk for developing CRCT (time frame: Baseline). 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 Aug 2026; AzTrials last refreshed its copy on 7 Nov 2026.