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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2022-05690 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| W81XWH-22-1-0289 | Other Grant/Funding Number | Department of Defense |
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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.
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 enrollment. Patients who develop cardiac toxicity may undergo additional collection of blood samples. Patients' medical records are also reviewed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biospecimen Collection | Procedure | Undergo collection of blood samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with breast cancer who have previously received chemotherapy, are currently being treated with chemotherapy, or are about to be treated with chemotherapy
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nadine Norton, Ph.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Recruiting | Gainesville | Florida | 32610 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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Blood
| Electronic Medical Record | Other | Review of medical records |
|
|
| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D057286 | Electronic Health Records |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
| D016347 | Medical Records Systems, Computerized |
| D008499 | Medical Records |
| D011996 | Records |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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