Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001143718
Ethics application status
Approved
Date submitted
15/08/2013
Date registered
14/10/2013
Date last updated
14/10/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessing the advantages and disadvantages of electronic laryngoscope, CT and MRI compared to serial sections on the anterior commissure in laryngeal carcinoma
Scientific title
Assessing the advantage and disadvantage of electronic laryngoscope, CT,MRI compare with Serial sections on the anterior commissure in laryngeal carcinoma.
Secondary ID [1] 283024 0
'Nil'
Universal Trial Number (UTN)
U1111-1146-7531
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anterior vocal commissure of laryngeal carcinomas 289856 0
Condition category
Condition code
Cancer 290215 290215 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
1.After informed consent,collected laryngeal squamous cell carcinoma patient's basic information, imaging data and anterior commissure specimen after open laryngeal resection who had been imaging diagnosed as anterior commissure suspected invaded(All participants undergo electronic laryngoscope,CT,MRI scan and open laryngeal resection).
2.Collected specimens were used to make serial sections,which considered as the gold standard for the diagnosis of invaded cancer
3.Compare the same level of CT or MRI scan with Serial sections, analyse degree of coincidence between imaging scan(CT, MRI) and pathological serial sections.
4.Discussion the diagnostic accuracy of imaging technologies on anterior commissure suspected invaded laryngeal squamous cell carcinoma,analyze the causes and propose the best diagnostic program.
Intervention code [1] 287745 0
Not applicable
Comparator / control treatment
Uncontrolled
Control group
Uncontrolled

Outcomes
Primary outcome [1] 290235 0
Primary Outcome 1: Serial sections of the anterior commissure involvement laryngeal tumor volume, depth and TNM staging.
Timepoint [1] 290235 0
Timepoint: after open surgery.
Primary outcome [2] 290236 0
Primary Outcome 2: Electronic laryngoscope, CT and MRI for tumor volume, depth and TNM staging.
Timepoint [2] 290236 0
Timepoint: before open surgery.
Secondary outcome [1] 304185 0
Secondary Outcome 1:Chi-square test was used to analyse degree of consistency between imaging scan(CT, MRI) and pathological serial sections.
Timepoint [1] 304185 0
Timepoint: After the evaluation of serial sections

Eligibility
Key inclusion criteria
1 patient informed and signed the "Informed Consent Forms";
2 shade examination highly suspected anterior commissure involvement;
3 patients who undergo open surgery.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1 with serious systemic diseases such as heart failure can not tolerate surgery;
2 After chemotherapy;
3 dropouts research.

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
26/08/2013
Actual
1/07/2013
Date of last participant enrolment
Anticipated
1/07/2014
Actual
8/09/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
35
Accrual to date
Final
Recruitment outside Australia
Country [1] 5294 0
China
State/province [1] 5294 0
Guangdong

Funding & Sponsors
Funding source category [1] 287787 0
Government body
Name [1] 287787 0
National Natural Science Foundation of China
Country [1] 287787 0
China
Primary sponsor type
Individual
Name
Lei wenbin ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
Address
Zhong shan 2nd Road 58,
Guangzhou 510080
Country
China
Secondary sponsor category [1] 286517 0
Individual
Name [1] 286517 0
Wen weiping ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
Address [1] 286517 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country [1] 286517 0
China

Ethics approval
Ethics application status
Approved

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 42170 0
Mr Wu jianhui ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
Address 42170 0
Zhong shan 2nd Road 58,
Guangzhou 510080
Country 42170 0
China
Phone 42170 0
+86-20-87333733
Fax 42170 0
Email 42170 0
463889820@qq.com
Contact person for public queries
Name 42171 0
Lei wenbin ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
Address 42171 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 42171 0
China
Phone 42171 0
+86-20-87333733
Fax 42171 0
+86-20-87333733
Email 42171 0
leiwb2003@yahoo.com.cn
Contact person for scientific queries
Name 42172 0
Lei wenbin ENT Hospital, First Affiliated Hospital of Sun Yat-sen University
Address 42172 0
Zhong shan 2nd Road 58,
Guangzhou 510080,
Country 42172 0
China
Phone 42172 0
+86-20-87333733
Fax 42172 0
+86-20-87333733
Email 42172 0
leiwb2003@yahoo.com.cn

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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