Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000067673
Ethics application status
Approved
Date submitted
4/01/2014
Date registered
21/01/2014
Date last updated
21/01/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Research on nasopharyngeal carcinoma with contrast-enhanced ultrasonography
Scientific title
Diagnostic accuracy of contrast-enhanced ultrasonography versus MRI for primary nasopharyngeal carcinoma
Secondary ID [1] 283845 0
None.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
nasopharyngeal carcinoma 290820 0
Condition category
Condition code
Cancer 291188 291188 0 0
Head and neck

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Patients suspected of having nasopharyngeal carcinoma (NPC) will do ultrasonography (US) and magnetic resonance (MR) imaging. A diagnosis was obtained from an endoscopic biopsy that was collected from the suspected tumor or a normal nasopharynx. US examinations and MR imaging were performed prior to the nasopharyngeal endoscopy so that the biopsy would not affect the images of the nasopharynx. There was approximately 30 minutes assessed on a single occasion only.
Intervention code [1] 288525 0
Not applicable
Comparator / control treatment
ultrasonography (US) versus magnetic resonance (MR) imaging
Control group
Uncontrolled

Outcomes
Primary outcome [1] 291176 0
The diagnostic performance of US and MR imaging for NPC was evaluated using receiver-operating curve (ROC) analysis.
Timepoint [1] 291176 0
US examinations and MR imaging were performed prior to the nasopharyngeal endoscopy so that the biopsy would not affect the images of the nasopharynx.
Secondary outcome [1] 306187 0
The sensitivity and specificity of the two imaging methods were compared using the McNemar test.
Timepoint [1] 306187 0
At the time of ultrasound.

Eligibility
Key inclusion criteria
Suspicion of NPC was based on the presence of metastatic cervical lymph nodes and/or a nasopharyngeal abnormality accompanied by nonspecific symptoms (e.g., epistaxis, nasal obstruction, hearing loss).
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients were excluded if they did not successfully undergo US, MR imaging, and an endoscopic biopsy, or if a non-NPC tumor of the nasopharynx was diagnosed.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/01/2013
Actual
1/01/2013
Date of last participant enrolment
Anticipated
29/03/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5715 0
China
State/province [1] 5715 0
Nanning, Guangxi

Funding & Sponsors
Funding source category [1] 288497 0
Charities/Societies/Foundations
Name [1] 288497 0
Guangxi Natural Science Fund Project
Country [1] 288497 0
China
Primary sponsor type
Individual
Name
Shang-Yong Zhu
Address
From the Department of Diagnostic Ultrasound, First Affiliated Hospital of Guangxi Medical University, 22 Shuangyong Rd, Nanning, Guangxi 530021, China
Country
China
Secondary sponsor category [1] 287202 0
None
Name [1] 287202 0
Address [1] 287202 0
Country [1] 287202 0

Ethics approval
Ethics application status
Approved

Summary
Brief summary
The aim of this prospective study was to determine whether ultrasonography represents a potential screening method for suspected cases of nasopharyngeal carcinoma, and to evaluate the imaging information provided by ultrasonography that can be applied to the clinical staging and treatment of nasopharyngeal carcinoma.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 45298 0
Mr Shang-Yong Zhu
Address 45298 0
From the Department of Diagnostic Ultrasound, First Affiliated Hospital of Guangxi Medical University, 22 Shuangyong Rd, Nanning, Guangxi 530021, China
Country 45298 0
China
Phone 45298 0
+86 13978896121
Fax 45298 0
Email 45298 0
[email protected]
Contact person for public queries
Name 45299 0
Mr Shang-Yong Zhu
Address 45299 0
From the Department of Diagnostic Ultrasound, First Affiliated Hospital of Guangxi Medical University, 22 Shuangyong Rd, Nanning, Guangxi 530021, China
Country 45299 0
China
Phone 45299 0
+86 13978896121
Fax 45299 0
Email 45299 0
[email protected]
Contact person for scientific queries
Name 45300 0
Mr Shang-Yong Zhu
Address 45300 0
From the Department of Diagnostic Ultrasound, First Affiliated Hospital of Guangxi Medical University, 22 Shuangyong Rd, Nanning, Guangxi 530021, China
Country 45300 0
China
Phone 45300 0
+86 13978896121
Fax 45300 0
Email 45300 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.