Ignite Creation Date:
2024-05-06 @ 10:20 AM
Last Modification Date:
2024-10-26 @ 12:28 PM
Study NCT ID:
NCT03235427
Status:
COMPLETED
Last Update Posted:
2019-05-21
First Post:
2017-06-06
Brief Title:
The CAROLE CArdiac Related Oncologic Late Effects Study
Sponsor:
Northwell Health
Organization:
Northwell Health
Study Overview
Official Title:
The CAROLE CArdiac Related Oncologic Late Effects Study
Status:
COMPLETED
Status Verified Date:
2019-05
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:
CAROLE
Brief Summary:
CAROLE seeks to evaluate the relationship between chest Radiation Therapy and coronary artery disease
The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease
The purpose of CAROLE is to check the heart health of women who received breast cancer treatments in the past and protect them from future heart disease
Detailed Description:
Background Within the United States there are an estimated 31 million women alive who have been diagnosed with invasive breast cancer and approximately 56 of them have received radiation Worldwide there are 14 million diagnosed annually and in 2012 it was the most commonly diagnosed cancer in women As patients continue to live longer cardiac dose-related toxicity has become an issue which impacts millions globally Guidelines are sorely needed for this large at-risk population of women
Purpose Radiation therapy to the chest has known cardiac late effects including coronary artery disease fibrosis and valvular dysfunction Unfortunately there is no clear evidence on which radiation doses to cardiac structures cause these late toxicities As a result these effects are often under-recognized until after patients have become symptomatic More than half of breast cancer patients are treated with radiation and many receive incidental cardiac irradiation Many of these women also receive systemic therapy which may pose additional cardiac risks The investigators data will help to establish baseline rates of pre-clinical and clinical disease which can be used to inform preventative guidelines that are critically needed in this at-risk population Additionally the investigators data will provide a better definition of the radiation dose-relationship associated with cardiac toxicity so that it will be possible to predict more accurately who is at elevated risk for iatrogenic cardiac disease
Research Plan This study will identify and evaluate 200 breast cancer patients treated at the investigators institution 6 years prior who are at risk for treatment-related cardiac toxicity All patients enrolled in the study will receive echocardiograms echo electrocardiograms EKGs and coronary calcium CAC CT scans in order to comprehensively evaluate for pre-clinical and clinical cardiac disease Patients identified as having cardiac disease during testing will be offered referral to a cardiologist Patients who received non-radiation treatments chemotherapy hormonal therapy andor surgery will be compared to radiated patients to establish baseline rates of preclinical and clinical disease Patients who received cardiotoxic systemic therapy doxorubicin trastuzumab etc will also be evaluated in subgroup analysis Among radiation patients this study proposes a novel method of risk assessment which is to utilize a patients stored treatment plan from 2004-2011 and fuse it with patients current cardiac imaging to delineate an accurate dose relationship associated with clinical and pre-clinical disease This is further described in the specific aims below
Specific Aim 1 Identify baseline levels of clinical and pre-clinical disease in breast cancer patients
Aim 11 Delineate the group of patients diagnosed and treated for breast cancer between 2004-2011 enroll health system patients with recent follow up within 3 years
Aim 12 Perform non-invasive cardiac testing EKG echo CAC CT scans Aim 13 Establish rates of pre-clinical and clinical disease based on pre-determined criteria
Specific Aim 2 Create an accurate dosimetric assessment of dose to cardiac structures
Aim 11 Among study patients who received radiation treatment for breast cancer obtain stored planning CT simulation scans
Aim 12 Upload CT simulation scans with dosimetric information and delineate cardiac structures at risk in order to ensure accurate and reproducible target delineation
Aim 13 Fuse the CAC CT scan with the CT simulation scan to accurately assess for dose correlation between coronary calcium with the dose received
Aim 14 Create a dose-relationship model for the heart and cardiac structures
Specific Aim 3 Incorporate dosimetric cardiac risk information into the investigators institutions clinical practice publish data and establish updated cardiac guidelines for women who have received radiation for breast cancer
The long-term goal of the project is to elucidate specific treatment and radiation dose-related risks which will then be used to inform follow-up recommendations and guidelines This project will impact the way investigators describe expected cardiac risk to patients the way the investigators recommend follow up care and potentially the way the investigators prescribe treatment At present all patients receiving radiation for breast cancer are informed that there is a risk of cardiac late effects however no specific cardiac imaging or intervention is recommended other than routine medical follow up There is little distinction given to the side of the cancer a patients individual anatomy or the projected dose to the anterior heart and cardiac structures This project will allow physicians to provide a more accurate risk profile regarding future risk of cardiac morbidity If the study reveals a very high rate of pre-clinical atherosclerotic disease it also may prompt more routine CAC CT screening
Purpose Radiation therapy to the chest has known cardiac late effects including coronary artery disease fibrosis and valvular dysfunction Unfortunately there is no clear evidence on which radiation doses to cardiac structures cause these late toxicities As a result these effects are often under-recognized until after patients have become symptomatic More than half of breast cancer patients are treated with radiation and many receive incidental cardiac irradiation Many of these women also receive systemic therapy which may pose additional cardiac risks The investigators data will help to establish baseline rates of pre-clinical and clinical disease which can be used to inform preventative guidelines that are critically needed in this at-risk population Additionally the investigators data will provide a better definition of the radiation dose-relationship associated with cardiac toxicity so that it will be possible to predict more accurately who is at elevated risk for iatrogenic cardiac disease
Research Plan This study will identify and evaluate 200 breast cancer patients treated at the investigators institution 6 years prior who are at risk for treatment-related cardiac toxicity All patients enrolled in the study will receive echocardiograms echo electrocardiograms EKGs and coronary calcium CAC CT scans in order to comprehensively evaluate for pre-clinical and clinical cardiac disease Patients identified as having cardiac disease during testing will be offered referral to a cardiologist Patients who received non-radiation treatments chemotherapy hormonal therapy andor surgery will be compared to radiated patients to establish baseline rates of preclinical and clinical disease Patients who received cardiotoxic systemic therapy doxorubicin trastuzumab etc will also be evaluated in subgroup analysis Among radiation patients this study proposes a novel method of risk assessment which is to utilize a patients stored treatment plan from 2004-2011 and fuse it with patients current cardiac imaging to delineate an accurate dose relationship associated with clinical and pre-clinical disease This is further described in the specific aims below
Specific Aim 1 Identify baseline levels of clinical and pre-clinical disease in breast cancer patients
Aim 11 Delineate the group of patients diagnosed and treated for breast cancer between 2004-2011 enroll health system patients with recent follow up within 3 years
Aim 12 Perform non-invasive cardiac testing EKG echo CAC CT scans Aim 13 Establish rates of pre-clinical and clinical disease based on pre-determined criteria
Specific Aim 2 Create an accurate dosimetric assessment of dose to cardiac structures
Aim 11 Among study patients who received radiation treatment for breast cancer obtain stored planning CT simulation scans
Aim 12 Upload CT simulation scans with dosimetric information and delineate cardiac structures at risk in order to ensure accurate and reproducible target delineation
Aim 13 Fuse the CAC CT scan with the CT simulation scan to accurately assess for dose correlation between coronary calcium with the dose received
Aim 14 Create a dose-relationship model for the heart and cardiac structures
Specific Aim 3 Incorporate dosimetric cardiac risk information into the investigators institutions clinical practice publish data and establish updated cardiac guidelines for women who have received radiation for breast cancer
The long-term goal of the project is to elucidate specific treatment and radiation dose-related risks which will then be used to inform follow-up recommendations and guidelines This project will impact the way investigators describe expected cardiac risk to patients the way the investigators recommend follow up care and potentially the way the investigators prescribe treatment At present all patients receiving radiation for breast cancer are informed that there is a risk of cardiac late effects however no specific cardiac imaging or intervention is recommended other than routine medical follow up There is little distinction given to the side of the cancer a patients individual anatomy or the projected dose to the anterior heart and cardiac structures This project will allow physicians to provide a more accurate risk profile regarding future risk of cardiac morbidity If the study reveals a very high rate of pre-clinical atherosclerotic disease it also may prompt more routine CAC CT screening
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