TRPC6 Characterization to Predict and Prevent Chemotherapy Related Cardiomyopathy and Heart Failure With Breast Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorMayo Clinic
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Patients with breast cancer who have previously received chemotherapy, are currently being treated with chemotherapy, or are about to be treated with chemotherapy
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Electronic Medical Record
Other interventionReview of medical records
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Ancillary-Correlative (biospecimen collection)2 interventions
Trial outcomes
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.
Time frame
Up to study completion, up to four years to completion.Sponsors and contacts
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Source ClinicalTrials.gov