Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma
NCT ID: NCT03568032
Last Updated: 2018-06-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
248 participants
OBSERVATIONAL
2018-07-01
2019-06-30
Brief Summary
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The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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the post-radiation group
patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago
Measurement of intima media thickness of carotid artery
IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.
Detection and measurement of carotid plaques
Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound
Carotid Color Flow Duplex Testing
Velocity measurement of carotid artery to determine carotid stenosis
Montreal Cognitive Assessment
Cognitive assessment
Medical history of cardiovascular risk factors and cardiovascular diseases
Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.
the pre-radiation group
untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma
Measurement of intima media thickness of carotid artery
IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.
Detection and measurement of carotid plaques
Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound
Carotid Color Flow Duplex Testing
Velocity measurement of carotid artery to determine carotid stenosis
Montreal Cognitive Assessment
Cognitive assessment
Medical history of cardiovascular risk factors and cardiovascular diseases
Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.
Interventions
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Measurement of intima media thickness of carotid artery
IMT measurements were performed using ultrasound machine in the pre-radiation and the post-radiation group. IMT was assessed at the common carotid artery (CCA) and the internal carotid artery (ICA) of both the left and right side.
Detection and measurement of carotid plaques
Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound
Carotid Color Flow Duplex Testing
Velocity measurement of carotid artery to determine carotid stenosis
Montreal Cognitive Assessment
Cognitive assessment
Medical history of cardiovascular risk factors and cardiovascular diseases
Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.
Eligibility Criteria
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Inclusion Criteria
* age more than 18 years old
* ECOG 0-2
* pathologic diagnosed, non-metastatic NPC
* either untreated or treated by definitive IMRT 3 years ago
* did not receive radiation to the head and neck region prior to the diagnosis of NPC
* if the patient received definitive IMRT 3 years ago because of NPC, he or she did not receive a second course of radiation due to local relapse
* no prior surgery of head and neck
Exclusion Criteria
* prior radiation to head and neck before the diagnosis of NPC
* prior surgery of head and neck
* pregnant or lactating women
18 Years
ALL
No
Sponsors
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Fudan University
OTHER
Responsible Party
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Xiayun He, MD
Principal Investigator, Clinical Professor
Principal Investigators
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Xiayun He, MD
Role: PRINCIPAL_INVESTIGATOR
Fudan University
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NPC-CAROTID-01
Identifier Type: -
Identifier Source: org_study_id
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