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Trial Title:
TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer
NCT ID:
NCT05507879
Condition:
Breast Carcinoma
Cardiotoxicity
Conditions: Official terms:
Breast Neoplasms
Heart Failure
Cardiomyopathies
Cardiotoxicity
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo collection of blood samples
Arm group label:
Ancillary-Correlative (biospecimen collection)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Electronic Medical Record
Description:
Review of medical records
Arm group label:
Ancillary-Correlative (biospecimen collection)
Other name:
Computer Based Patient Record
Other name:
EMR
Other name:
EMR (electronic medical record)
Summary:
This study examines TRPC6 in predicting and preventing chemotherapy related cardiac
toxicity and heart failure in patients with breast cancer. Cardiac toxicity, changes in
heart function is a well-recognized complication of certain cancer related therapies.
Understanding these changes may allow early intervention against therapy-related cardiac
toxicity and also identify novel therapeutic targets to protect patient long-term cardiac
health. Studying samples of blood from patients with breast cancer in the laboratory may
help doctors learn more about changes that occur in deoxyribonucleic acid (DNA), identify
biomarkers related to cardiac toxicity, and prevent the development of therapy-induced
cardiac toxicity in patients receiving chemotherapy.
Detailed description:
PRIMARY OBJECTIVE:
I. Characterize TRPC6 risk variants for doxorubicin-related cardiotoxicity in
prospectively collected samples from breast cancer patients.
OUTLINE: This is an ancillary-correlative study.
Patients undergo collection of blood samples at time of therapy initiation. Patients who
develop cardiac toxicity may undergo additional collection of blood samples. Patients'
medical records are also reviewed.
Criteria for eligibility:
Study pop:
Patients with breast cancer who have previously received chemotherapy or are about to be
treated with chemotherapy
Sampling method:
Non-Probability Sample
Criteria:
Inclusion Criteria:
- 18 years of age or older
- Any breast cancer patient initiating doxorubicin/other anthracycline and patients
receiving trastuzumab without doxorubicin/anthracycline in the neoadjuvant/adjuvant
setting
- An understanding of the protocol and its requirements, risks, and discomforts
- The ability and willingness to sign an informed consent
- Diagnosed with therapy related 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 OR completed chemotherapy
with no cardiotoxicity at least two years post treatment OR patients with cancer who
will be initiating systemic therapy with potentially cardiotoxic medications. This
will include doxorubicin chemotherapy, or trastuzumab.
- Healthy, non-pregnant, adult subjects who weigh at least 110 pounds
Exclusion Criteria:
- Inability on the part of the patient to understand the informed consent or be
compliant with the protocol
- Anemia with hemoglobin less than 8
- Patients not willing to undergo a blood draw
- Patients with stage IV or distant metastatic breast cancer
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Florida
Address:
City:
Gainesville
Zip:
32610
Country:
United States
Status:
Not yet recruiting
Contact:
Last name:
Katelyn Bruno, Ph.D.
Phone:
352-273-8933
Email:
katelyn.bruno@ufl.edu
Investigator:
Last name:
Katelyn Bruno, Ph.D.
Email:
Principal Investigator
Facility:
Name:
Mayo Clinic in Florida
Address:
City:
Jacksonville
Zip:
32224-9980
Country:
United States
Status:
Recruiting
Contact:
Last name:
Clinical Trial Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Nadine Norton, Ph.D.
Email:
Principal Investigator
Start date:
August 18, 2022
Completion date:
September 1, 2027
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05507879
https://www.mayo.edu/research/clinical-trials
