Nasopharyngeal CarcinomaNCT03568032
Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma
An observational study of Nasopharyngeal Carcinoma and Carotid Artery Diseases, run by Fudan University at 1 site in China.
Trial summary
Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Nasopharyngeal Carcinoma, Carotid Artery Diseases
- What is being tested?
- Measurement of intima media thickness of carotid artery, Detection and measurement of carotid plaques and Carotid Color Flow Duplex Testing
- How many people
- 248 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2018to 30 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population is selected from new patients or post-radiation patients who come to the clinics of radiation oncology.
Who may be able to join
- signed inform consent
- 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
Who cannot join
- prior history of cardiovascular disease before the diagnosis of NPC
- prior radiation to head and neck before the diagnosis of NPC
- prior surgery of head and neck
- pregnant or lactating women
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Xiayun He, MD, +86-18017312167, hexiayun1962@126.com
Xiaomin Ou, MD, +86-13816287320, doctorou1012@163.com
About this study
Official title: The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT
Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).
The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).
- Conditions
- Nasopharyngeal Carcinoma, Carotid Artery Diseases
- Being tested
- Measurement of intima media thickness of carotid artery, Detection and measurement of carotid plaques, Carotid Color Flow Duplex Testing, Montreal Cognitive Assessment, Medical history of cardiovascular risk factors and cardiovascular diseases
- Keywords
- intima media thickness
- Medical subject headings
- Nasopharyngeal Carcinoma, Carotid Artery Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of intima media thickness of carotid arteryDiagnostic test
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 plaquesDiagnostic test
Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound
Carotid Color Flow Duplex TestingDiagnostic test
Velocity measurement of carotid artery to determine carotid stenosis
Montreal Cognitive AssessmentDiagnostic test
Cognitive assessment
Medical history of cardiovascular risk factors and cardiovascular diseasesOther
Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.
| Study group | Role | What they receive |
|---|---|---|
| the post-radiation group | patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago Receives: Diagnostic Test: Measurement of intima media thickness of carotid artery; Diagnostic Test: Detection and measurement of carotid plaques; Diagnostic Test: Carotid Color Flow Duplex Testing; Diagnostic Test: Montreal Cognitive Assessment; Other: Medical history of cardiovascular risk factors and cardiovascular diseases | |
| the pre-radiation group | untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma Receives: Diagnostic Test: Measurement of intima media thickness of carotid artery; Diagnostic Test: Detection and measurement of carotid plaques; Diagnostic Test: Carotid Color Flow Duplex Testing; Diagnostic Test: Montreal Cognitive Assessment; Other: Medical history of cardiovascular risk factors and cardiovascular diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
intima media thickness of carotid artery
the intima media thickness of common carotid artery, internal carotid artery of the left or right side
Measured: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
Secondary outcomes (3)
the incidence of carotid stenosis
Carotid stenosis is defined as the axial diameter of the carotid lumina decreases more than 50%.
Measured: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
the number of carotid plaques
Carotid plaque is defined as a focal structure that encroaches into the arterial lumen of at least 0.5 mm or 50% of the surrounding IMT value or demonstrates a thickness >1.5 mm as measured from the media-adventitia interface to the intima- lumen interface.
Measured: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
total number of Montreal Cognitive Score (range: 0-30)
the higher the number, the better the cognitive function
Measured: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2018
- Study start1 Jul 2018 (estimated)
- Primary completion1 May 2019 (estimated)
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiayun He, MD, Fudan University
- Investigators
- Xiayun He, MD, Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03568032
- Sponsor's protocol ID
- NPC-CAROTID-01
- Status last verified
- Jun 2018
- First submitted
- 29 Mar 2018
- Last updated
- 26 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT
- ClinicalTrials.gov ID
- NCT03568032
- Acronym / sponsor ID
- NPC-CAROTID-01
- Conditions
- Nasopharyngeal Carcinoma, Carotid Artery Diseases
- Keywords
- intima media thickness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2018 (estimated)
- Primary completion
- 1 May 2019 (estimated)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 26 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Radiation-associated carotid vasculopathy is a common late sequelae in patients with head and neck cancer, which correlates with the incidence of stroke. Currently, little is known about the incidence of radiation-associated carotid vasculopahty in the context of intensity-modulated radiation therapy (IMRT).
The aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the post-radiation group | – | Diagnostic Test: Measurement of intima media thickness of carotid artery, Diagnostic Test: Detection and measurement of carotid plaques, Diagnostic Test: Carotid Color Flow Duplex Testing, Diagnostic Test: Montreal Cognitive Assessment, Other: Medical history of cardiovascular risk factors and cardiovascular diseasespatients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago |
| the pre-radiation group | – | Diagnostic Test: Measurement of intima media thickness of carotid artery, Diagnostic Test: Detection and measurement of carotid plaques, Diagnostic Test: Carotid Color Flow Duplex Testing, Diagnostic Test: Montreal Cognitive Assessment, Other: Medical history of cardiovascular risk factors and cardiovascular diseasesuntreated patients diagnosed as non-metastatic nasopharyngeal carcinoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population is selected from new patients or post-radiation patients who come to the clinics of radiation oncology.
Key inclusion criteria (8 listed)
- signed inform consent
- age more than 18 years old
- ECOG 0-2
- pathologic diagnosed, non-metastatic NPC
- either untreated or treated by definitive IMRT 3 years ago
Key exclusion criteria (4 listed)
- prior history of cardiovascular disease before the diagnosis of NPC
- prior radiation to head and neck before the diagnosis of NPC
- prior surgery of head and neck
- pregnant or lactating women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of intima media thickness of carotid arteryIMT 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. | Diagnostic test | the post-radiation group, the pre-radiation group |
| Detection and measurement of carotid plaquesDetection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound | Diagnostic test | the post-radiation group, the pre-radiation group |
| Carotid Color Flow Duplex TestingVelocity measurement of carotid artery to determine carotid stenosis | Diagnostic test | the post-radiation group, the pre-radiation group |
| Montreal Cognitive AssessmentCognitive assessment | Diagnostic test | the post-radiation group, the pre-radiation group |
| Medical history of cardiovascular risk factors and cardiovascular diseasesCardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc. | Other | the post-radiation group, the pre-radiation group |
Primary outcome
intima media thickness of carotid artery
Time frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
the intima media thickness of common carotid artery, internal carotid artery of the left or right side
3 secondary outcomes
the incidence of carotid stenosis
Time frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
the number of carotid plaques
Time frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
total number of Montreal Cognitive Score (range: 0-30)
Time frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiayun He, MD principal investigator
Fudan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Nasopharyngeal Carcinoma and Carotid Artery Diseases, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiaomin Ou, MD (+86 13816287320, doctorou1012@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intima media thickness of carotid artery (time frame: This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2018.