Trials Sponsors Conditions Drugs Pricing

Conditions

Cardiovascular Complication Carotid Artery Stenosis Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (9)

Change in Intima-Media Thickness (IMT)
At time of ultrasound, up to approximately 1 year
Number of Participants with Carotid Intima-Media Thickness (IMT) Increase
At time of ultrasound, up to approximately 1 year
Number of Participants with Carotid Plaque Thickness Increase
At time of ultrasound, up to approximately 1 year
Number of Participants Identified at High Risk of Cardiovascular Events
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
At time of ultrasound, up to approximately 1 year
+4 more secondary outcomes

Study Arms (1)

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.

Procedure: Carotid ultrasoundOther: Blood drawOther: Survey

Interventions

Carotid ultrasoundProcedure

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

Carotid Ultrasound Group

Blood drawOther

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

Carotid Ultrasound Group

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

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.

You may qualify if:

History of head and neck cancer treated with radiotherapy. Radiotherapy target volume(s) must have included at least one region of the neck to a total dose of at least 45 gray (Gy).

Sponsors & Collaborators

Wake Forest University Health Sciences
Otherlead

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Related Publications (1)

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.
PMID: 39230469DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Head and Neck NeoplasmsCarotid Stenosis

Interventions

Blood Specimen CollectionSurveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsCarotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

Ryan Hughes, MD
Wake Forest Comprehensive Cancer Center
PRINCIPAL INVESTIGATOR

Enrollment

60 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

December 2, 2022

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Carotid Ultrasound Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (9)

Study Arms (1)

Carotid Ultrasound Group

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Biospecimen

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Intervention Hierarchy (Ancestors)

Data Sharing

Source record

Locations