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NCT05490875Completed

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

Source: ClinicalTrials.gov · Last updated 17 Jan 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
60 (actual)
First submitted
4 Aug 2022
Start date
2 Dec 2022
Primary completion date
7 Jan 2025
Lead sponsor
Wake Forest University Health Sciences
NCT number
NCT05490875

What you commit to

  • Study type: Observational
  • Participants enrolled: 60
  • From 2 Dec 2022 to the primary completion date, 7 Jan 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior carotid artery ultrasound examination between completion of radiotherapy and registration.
  • Most recent radiotherapy treatment was for any recurrence of a prior head and neck cancer and/or treatment for a subsequent head and neck cancer after diagnosis and treatment of an initial head and neck cancer.
  • Any history of re-irradiation to the head and neck region. Re-irradiation is defined as a subsequent individual course of radiotherapy where the target overlaps a region of the head/neck that was previously targeted by the initial course of radiotherapy.

Other illness

  • Personal history of any of the following: Carotid artery stenosis on either side of the neck, stroke (CVA) or transient ischemic attack (TIA), carotid endarterectomy, carotid stent placement.

Other

  • ECOG Performance Status of 2 or greater.

Who the study is looking for

  • 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).
  • At least 2 years since completion of radiotherapy with no evidence of disease at the time of last clinical follow-up.
  • Eligible by Screening Questionnaire.
  • Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Wake Forest Baptist Comprehensive Cancer Center
Coordinator of this site? Confirm its status
Winston-SalemUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.