Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05078190
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-02-23
First Post:
2021-10-12
Brief Title:
Mechanisms Predictors and Social Determinants of Cardiotoxicity in Breast Cancer
Sponsor:
Abramson Cancer Center at Penn Medicine
Organization:
Abramson Cancer Center at Penn Medicine
Study Overview
Official Title:
Cardiotoxicity of Cancer Therapy 2 Mechanisms Predictors and Social Determinants of Health in Breast Cancer Patients Treated with Doxorubicin Andor Trastuzumab
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CCT2
Brief Summary:
This is an observational study for patients with breast cancer that will be treated with doxorubicin Adriamycin andor trastuzumab Herceptin The study will help the investigators learn more about how these medications affect the heart and how those effects relate to patients medical history and social determinants of health such as race gender identity education occupation access to health services and economic resources Patients on this study will have echocardiograms blood draws and answer questions about their symptoms and activity level Patients will be followed on this study for up to 15 years
Detailed Description:
The investigators propose a prospective longitudinal cohort of breast cancer patients treated with anthracyclines andor trastuzumab to determine the associations between social determinants of health SDOH and cardiotoxicity risk and to determine whether associations between SDOH and cardiotoxicity risk differ according to race Patients will be followed with serial echo blood draw and surveys every 3 months for the first year then annually for two years After 3 years following start of cancer therapy patients will have study visits every other year for up to 15 years
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None