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

NCT05507879 | Recruiting

• 3 other identifiers: 22-001501NCI-2022-05690W81XWH-22-1-0289
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Breast Carcinoma; Cardiomyopathy; Congestive Heart Failure

Outcome Measures

Primary Outcomes (1)

• Significance ofTRPC6 coding sequencing

  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.

Study Arms (1)

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; Other: Electronic Medical Record

Interventions

Biospecimen Collection PROCEDURE

Undergo collection of blood samples

Also known as: Biological Sample Collection, Biospecimen Collected, Specimen Collection

Ancillary-Correlative (biospecimen collection)

Electronic Medical Record OTHER

Review of medical records

Also known as: Computer Based Patient Record, EMR, EMR (electronic medical record)

Ancillary-Correlative (biospecimen collection)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (2)

University of Florida

Gainesville, Florida, 32610, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Breast Neoplasms; Cardiomyopathies; Heart Failure

Interventions

Specimen Handling; Electronic Health Records

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Medical Records Systems, Computerized; Medical Records; Records; Data Collection; Epidemiologic Methods; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Nadine Norton, Ph.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 19, 2022
• Study Start: September 26, 2022
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: February 10, 2026

Record last verified: 2026-02

Locations

US (2)