Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiac Toxicity and Heart Failure in Patients With Breast Cancer

• Sponsor: Mayo Clinic (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05507879
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 300
• Location: 1
• Anticipated Duration (Months): 60
• Patients Per Site Per Month: 5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Carcinoma; Cardiotoxicity	Procedure: Biospecimen Collection; Other: Electronic Medical Record

Detailed Description

PRIMARY OBJECTIVE:

1. 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 Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Characterization of TRPC6 to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure (Prospective Study)
• Anticipated Study Start Date: Sep 1, 2022
• Anticipated Primary Completion Date: Sep 1, 2026
• Anticipated Study Completion Date: Sep 1, 2027

Arms and Interventions

Arm	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)

Outcome Measures

Primary Outcome Measures

1. Significance ofTRPC6 coding sequencing [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic in Florida	Jacksonville	Florida	United States	32224-9980

Sponsors and Collaborators

• Mayo Clinic
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Nadine Norton, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mayo Clinic
• ClinicalTrials.gov Identifier: NCT05507879
• Other Study ID Numbers: 22-001501; NCI-2022-05690; 22-001501; P30CA015083
• First Posted: Aug 19, 2022
• Last Update Posted: Aug 19, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Breast Neoplasms; Heart Failure; Cardiotoxicity

Study Results

No Results Posted as of Aug 19, 2022