Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-25 @ 7:37 PM
Study NCT ID:
NCT03568032
Status:
UNKNOWN
Last Update Posted:
2018-06-26
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077274', 'term': 'Nasopharyngeal Carcinoma'}, {'id': 'D002340', 'term': 'Carotid Artery Diseases'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009303', 'term': 'Nasopharyngeal Neoplasms'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009302', 'term': 'Nasopharyngeal Diseases'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 248}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2018-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2019-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-06-13', 'studyFirstSubmitDate': '2018-03-29', 'studyFirstSubmitQcDate': '2018-06-13', 'lastUpdatePostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intima media thickness of carotid artery', 'timeFrame': 'This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.', 'description': 'the intima media thickness of common carotid artery, internal carotid artery of the left or right side'}], 'secondaryOutcomes': [{'measure': 'the incidence of carotid stenosis', 'timeFrame': 'This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.', 'description': 'Carotid stenosis is defined as the axial diameter of the carotid lumina decreases more than 50%.'}, {'measure': 'the number of carotid plaques', 'timeFrame': 'This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.', 'description': '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.'}, {'measure': 'total number of Montreal Cognitive Score (range: 0-30)', 'timeFrame': 'This is a cross-sectional study. So the time frame is within one week of a patient-visit to the clinics.', 'description': 'the higher the number, the better the cognitive function'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['intima media thickness'], 'conditions': ['Nasopharyngeal Carcinoma', 'Carotid Artery Diseases']}, 'descriptionModule': {'briefSummary': '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).\n\nThe aim of this study is to determine whether IMRT will increase the incidence of carotid vasculopathy in patients with nasopharyngeal carcinoma (NPC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population is selected from new patients or post-radiation patients who come to the clinics of radiation oncology.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed inform consent\n* age more than 18 years old\n* ECOG 0-2\n* pathologic diagnosed, non-metastatic NPC\n* either untreated or treated by definitive IMRT 3 years ago\n* did not receive radiation to the head and neck region prior to the diagnosis of NPC\n* 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\n* no prior surgery of head and neck\n\nExclusion Criteria:\n\n* prior history of cardiovascular disease before the diagnosis of NPC\n* prior radiation to head and neck before the diagnosis of NPC\n* prior surgery of head and neck\n* pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT03568032', 'briefTitle': 'Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Fudan University'}, 'officialTitle': 'The Clinical Study of Radiation-associated Carotid Artery Disease in Patients With Nasopharyngeal Carcinoma Treated by IMRT', 'orgStudyIdInfo': {'id': 'NPC-CAROTID-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'the post-radiation group', 'description': 'patients diagnosed as non-metastatic nasopharyngeal carcinoma who received definitive IMRT more than 3 years ago', 'interventionNames': ['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']}, {'label': 'the pre-radiation group', 'description': 'untreated patients diagnosed as non-metastatic nasopharyngeal carcinoma', 'interventionNames': ['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']}], 'interventions': [{'name': 'Measurement of intima media thickness of carotid artery', 'type': 'DIAGNOSTIC_TEST', 'description': '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.', 'armGroupLabels': ['the post-radiation group', 'the pre-radiation group']}, {'name': 'Detection and measurement of carotid plaques', 'type': 'DIAGNOSTIC_TEST', 'description': 'Detection and measurement of plaques within internal carotid artery and common carotid artery by ultrasound', 'armGroupLabels': ['the post-radiation group', 'the pre-radiation group']}, {'name': 'Carotid Color Flow Duplex Testing', 'type': 'DIAGNOSTIC_TEST', 'description': 'Velocity measurement of carotid artery to determine carotid stenosis', 'armGroupLabels': ['the post-radiation group', 'the pre-radiation group']}, {'name': 'Montreal Cognitive Assessment', 'type': 'DIAGNOSTIC_TEST', 'description': 'Cognitive assessment', 'armGroupLabels': ['the post-radiation group', 'the pre-radiation group']}, {'name': 'Medical history of cardiovascular risk factors and cardiovascular diseases', 'type': 'OTHER', 'description': 'Cardiovascular risk factors include smoking, alcohol consumption, hypertension, diabetes mellitus, hypercholesterolemia, obesity. Cardiovascular diseases include ischemic stroke, ischemic coronary heart disease, TIA, etc.', 'armGroupLabels': ['the post-radiation group', 'the pre-radiation group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200032', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xiayun He, MD', 'role': 'CONTACT', 'email': 'hexiayun1962@126.com', 'phone': '+86-18017312167'}, {'name': 'Xiaomin Ou, MD', 'role': 'CONTACT', 'email': 'doctorou1012@163.com', 'phone': '+86-13816287320'}], 'facility': 'Fudan University Shanghai Cancer Center', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xiaomin Ou, MD', 'role': 'CONTACT', 'email': 'doctorou1012@163.com', 'phone': '+86 13816287320'}], 'overallOfficials': [{'name': 'Xiayun He, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fudan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fudan University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator, Clinical Professor', 'investigatorFullName': 'Xiayun He, MD', 'investigatorAffiliation': 'Fudan University'}}}}