Neoplasms

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Heart and Blood Diseases

Head and Neck Neoplasms

Constriction, Pathologic

Carotid Stenosis

Carotid Artery Diseases

Cerebrovascular Disorders

Brain Diseases

Central Nervous System Diseases

Arterial Occlusive Diseases

Vascular Diseases

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.

Carotid ultrasound will be done to both sides of the neck to look at the carotid arteries.

Carotid ultrasound

This optional blood draw could occur anytime from the time of enrollment on the study until 90 days after the research ultrasound.

Blood draw

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.

Survey

Study Coordinator

Study Nurse

Ryan Hughes, MD

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:

* To measure the intima-media thickness (IMT) of the carotid arteries in head and neck cancer survivors treated with head and neck radiotherapy.
* To determine the proportion of patients with carotid intima-media thickness of at least 0.9 mm in head and neck cancer survivors treated with head and neck radiotherapy.
* To determine the proportion of patients with carotid plaque of maximum thickness 2 mm or greater in head and neck cancer survivors treated with head and neck radiotherapy.
* To determine the proportion of patients identified as having a high risk of cardiovascular events (relative risk 1.50 or greater) based on intima-media thickness measurements in head and neck cancer survivors treated with head and neck radiotherapy.
* To describe the risk of significant carotid artery stenosis based on various clinical factors in head and neck cancer survivors treated with head and neck radiotherapy.
* To determine the feasibility of carotid ultrasound in head and neck cancer survivors treated with head and neck radiotherapy.
* To obtain preliminary data on the acceptability of carotid ultrasound among head and neck cancer survivors treated with head and neck radiotherapy.
* To obtain preliminary data on barriers to potential carotid ultrasound screening in head and neck cancer survivors treated with head and neck radiotherapy.
* To obtain preliminary data on stroke risk perception among head and neck cancer survivors treated with radiotherapy in head and neck cancer survivors treated with head and neck radiotherapy.

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.

Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy

A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

Wake Forest University Health Sciences

Rare Diseases

Hemorrhage

Glioma

Brain Neoplasms

Aneurysm

Intracranial Hemorrhages

Intracranial Aneurysm

Central Nervous System Neoplasms

Nervous System Neoplasms

Intracranial Arterial Diseases

biological samples analysis

Xiaolin Chen, MD

Fa Lin, MD

Runting Li, MD

Yitong Jia, MD

Ke Wang, MD

Plastic particles are a ubiquitous pollutant in the living environment and food chain, so far, plenty of studies have reported the internal exposure of microplastics and nanoplastics in human tissues and enclosed body fluids.

Neurosurgery is the only department that can open the skull. In addition to blood and cerebrospinal fluid, there are brain tissue and tumors in the presence of lesions. Whether any of these microplastics and nanoplastics are present remains a mystery. This prospective observational study will harvest biological samples of neurosurgery patients.

The objective of this research is to be able to detect microplastics and nanoplastics on blood and operation samples of neurosurgery patients.

Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)

Presence of Microplastics and Nanoplastics in Neurosurgery Patients

Detection of microplastics in human brain tissue and the blood undergoing neurosurgery

Detection of nanoplastics in human brain tissue and the blood undergoing neurosurgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy	NCT05490875	Head and Neck C... Carotid Artery ... Cardiovascular ...	Carotid ultraso... Blood draw Survey	18 Years -	Wake Forest University Health Sciences
Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy	NCT05490875	Head and Neck C... Carotid Artery ... Cardiovascular ...	Carotid ultraso... Blood draw Survey	18 Years -	Wake Forest University Health Sciences
Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)	NCT05968053	Carotid Artery ... Glioma Intracranial An... Intracranial He... Brain Tumor	biological samp...	18 Years - 80 Years	Beijing Tiantan Hospital

Spots Global Cancer Trial Database for carotid artery stenosis