TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer

February 23, 2024 updated by: Mayo Clinic

Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Not yet recruiting
        • University of Florida
        • Contact:
        • Principal Investigator:
          • Katelyn Bruno, Ph.D.
      • Jacksonville, Florida, United States, 32224-9980
        • Recruiting
        • Mayo Clinic in Florida
        • Contact:
        • Principal Investigator:
          • Nadine Norton, Ph.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with breast cancer who have previously received chemotherapy or are about to be treated with chemotherapy

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Ancillary-Correlative (biospecimen collection)
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.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Other: Electronic Medical Record
Review of medical records
Other Names:
  • Computer Based Patient Record
  • EMR
  • EMR (electronic medical record)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Significance ofTRPC6 coding sequencing
Time Frame: Up to study completion, up to four years to completion.
Will compare the prevalence of rare missense variants in our cases against the null hypothesis to assess the significance of TRPC6 coding sequencing data in patients with dox-induced heart failure (HF). Will use an exploratory analysis to estimate the prevalence, 95% confidence intervals and p-values depending on the number of patients with rare variants in the data set and due to the rarity (i.e. high degree of conservation in the TRPC6 coding sequence).Other methods include biospecimen collection and the TRPC6 coding sequence. Data collected will be stored in a database and studied by the PI.
Up to study completion, up to four years to completion.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Nadine Norton, Ph.D., Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 18, 2022

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

August 8, 2022

First Submitted That Met QC Criteria

August 17, 2022

First Posted (Actual)

August 19, 2022

Study Record Updates

Last Update Posted (Actual)

February 28, 2024

Last Update Submitted That Met QC Criteria

February 23, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22-001501 (Mayo Clinic in Florida)
  • P30CA015083 (U.S. NIH Grant/Contract)
  • NCI-2022-05690 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • W81XWH-22-1-0289 (Other Grant/Funding Number: Department of Defense)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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