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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 98322 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center |
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The purpose of this research study is to understand how radiation therapy may affect blood vessels in the neck called the carotid arteries. Investigators want to look at narrowing of the artery or thickening of the walls of the arteries.
Primary Objective: To determine the proportion of patients with clinically significant carotid artery stenosis (≥50% stenosis) in head and neck cancer survivors treated with head and neck radiotherapy.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Carotid Ultrasound Group | Head and neck cancer survivors treated with radiotherapy, at least 2 years since end of radiotherapy with no evidence of disease will receive a carotid ultrasound to measure carotid velocities and intima-media thickness of the carotid arteries. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carotid ultrasound | Procedure | Carotid ultrasound will be done to both sides of the neck to look at the carotid arteries. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with 50% Stenosis Identified | This will be defined as having a peak systolic flow velocity of 150 cm/s or higher on Doppler ultrasonography will be estimated and reported along with an exact 95% confidence interval. | At study completion, up to 1 approximately year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Intima-Media Thickness (IMT) | Mean, median, standard deviation and interquartile range will be used to describe IMT as a continuous variable at three separate angles (anterior, lateral and posterior). IMT will be measured in millimeters at 3 separate angles (anterior, lateral, and posterior) at the level of the distal common carotid artery, carotid bulb at the flow divider, and the proximal internal carotid artery. |
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Inclusion Criteria:
Exclusion Criteria:
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Participants will be screened through the radiation oncology clinic and by review of the electronic medical record for visits with head and neck radiation therapy providers.
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| Name | Affiliation | Role |
|---|---|---|
| Ryan Hughes, MD | Wake Forest Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39230469 | Derived | Hughes RT, Snavely AC, Dressler EV, Tegeler CH, Nightingale CL, Furdui CM, Soto Pantoja DR, Register TC, Weaver KE, Lesser GJ. Carotid ultrasound to identify head and neck cancer survivors with high cardiovascular risk after radiation therapy: rationale and design of a prospective, cross-sectional pilot study. Future Oncol. 2024;20(31):2331-2341. doi: 10.1080/14796694.2024.2386927. Epub 2024 Sep 4. |
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Peripheral blood (total 16 mL) will be obtained from patients who opt to provide these samples. Plasma and peripheral blood mononuclear cells (PBMC) will be banked for the following planned correlative analyses, pending further funding. Upon collection, these samples will be collected (see Correlative Blood Specimen Collection Form), transported to and processed/stored by the NCORP Biorepository for future analysis. If funding is not obtained for correlative studies by the closure of this study, samples will be retained indefinitely for future study.
| Blood draw | Other | This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound. |
|
| Survey | Other | Participants will complete a 15-minute survey about how acceptable participants find the ultrasound procedure, whether participants would be open to it in the future if a doctor thought it was necessary, whether participants would be open to getting treatment for artery problems, and how participants feel about their own risk of stroke. |
|
| At time of ultrasound, up to approximately 1 year |
| Number of Participants with Carotid Intima-Media Thickness (IMT) Increase | Participants with at least one carotid IMT measurements of 0.9 mm or greater based on IMT measurements will be each be estimated and reported along with an exact 95% confidence interval. | At time of ultrasound, up to approximately 1 year |
| Number of Participants with Carotid Plaque Thickness Increase | Participants with carotid plaque of maximum thickness 2 mm or greater and with high risk of cardiovascular events (relative risk 1.50 or greater) based on IMT measurements will be each be estimated and reported along with an exact 95% confidence interval. | At time of ultrasound, up to approximately 1 year |
| Number of Participants Identified at High Risk of Cardiovascular Events | Participants identified as clinically significant (relative risk 1.50 or greater) may be estimated and reported along with an exact 95% confidence interval within subgroups defined by clinical characteristics. | At time of ultrasound, up to approximately 1 year |
| Number of Participants with Clinically Significant Carotid Artery Stenosis (Greater than or Equal to 50%) Based on Potential Risk Factors | Associations between continuous clinical characteristics and clinically significant carotid artery stenosis will be evaluated using t-tests or Wilcoxon rank-sum tests. Potential risk factors used to evaluate will be gender; age; systolic blood pressure at time of ultrasound; history of cigarette smoking; history of prior cardiovascular disease; history of atrial fibrillation; left ventricular hypertrophy on echocardiogram; use of anti-hypertensive medication; radiation dose to the exposed carotid artery | At time of ultrasound, up to approximately 1 year |
| Number of Participants Enrolled that Receive Study Intervention - Feasibility | The study will be considered feasible if 60% of responding participants enroll and receive carotid ultrasound. If less than 40% of responding participants enroll and receive the study carotid ultrasound, investigators will re-evaluate methods for subsequent study. This will be be reported with an exact 95% confidence interval. | At time of enrollment, up to approximately 1 year |
| Acceptability of Intervention Measure Instrument (Likert scale). | Descriptive statistics will be used to characterize acceptability of carotid ultrasound. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and treatment options. | At study completion, up to approximately 1 year |
| Barriers Survey instrument (Likert scale) | Descriptive statistics will be used to characterize barriers to getting a carotid ultrasound. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and/or treatment options. | At study completion, up to approximately 1 year |
| Assessment of Risk Perception Instrument (Likert scale) | Descriptive statistics will be used to characterize stroke risk perception. Scoring scale is a Likert scale (completely disagree to completely agree) with completely agree being scored as a more positive response to the intervention and/or treatment options. | At study completion, up to approximately 1 year |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D016893 | Carotid Stenosis |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002340 | Carotid Artery Diseases |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| 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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