UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010926
Receipt No. R000012785
Scientific Title Endoscopic findings detected using narrow-band imaging to distinguish between basal cell hyperplasia and squamous cell carcinoma of the pharynx
Date of disclosure of the study information 2013/06/11
Last modified on 2013/06/11

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Endoscopic findings detected using narrow-band imaging to distinguish between basal cell hyperplasia and squamous cell carcinoma of the pharynx
Acronym NBI findings of BCH in the pharynx
Scientific Title Endoscopic findings detected using narrow-band imaging to distinguish between basal cell hyperplasia and squamous cell carcinoma of the pharynx
Scientific Title:Acronym NBI findings of BCH in the pharynx
Region
Japan

Condition
Condition Basal cell hyperplasia of the pharynx and superficial-type head and neck squamous cell carcinoma
Classification by specialty
Gastroenterology Oto-rhino-laryngology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of the present study was to clarify the endoscopic characteristics of basal cell hyperplasia that contribute to the discrimination of superficial-type head and neck squamous cell carcinoma.
Basic objectives2 Others
Basic objectives -Others The aim of the present study was to clarify the endoscopic characteristics of basal cell hyperplasia that contribute to the discrimination of superficial-type head and neck squamous cell carcinoma.
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The size, intervascular transparency, variety of IPCL (intra-epithelial papillary capillary loop) shapes, and the distribution of the IPCLs
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients who were pathologically diagnosed as having BCH based on endoscopic biopsy samples of the pharynx obtained between January 2008 and July 2012 at our institute.
Key exclusion criteria Cases without NBI-ME images or with only inappropriate images (blurry or unfocused) were excluded.
Target sample size 63

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhiro Kaneko
Organization National Cancer Center East
Division name Department of Gastroenterology, Endoscopy Division
Zip code
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization National Cancer Center East
Division name Department of Gastroenterology, Endoscopy Division
Zip code
Address
TEL
Homepage URL
Email ayagishi@east.ncc.go.jp

Sponsor
Institute National Cancer Center East
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2013 Year 06 Month 11 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The size of the BCH lesions was significantly smaller (P < 0.001), and their intervascular transparency was more clearly observed (P < 0.001).  IPCL (intra-epithelial papillary capillary loop) shapes were less variable and monotonous (P < 0.001), and the distribution of the IPCLs was more regular with an interval comparable to that of SCC (P < 0.001), though no significant differences in the sharpness of the lesion border or the morphological changes in the IPCLs were seen between the BCH and SCC lesions.
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 01 Month 22 Day
Date of IRB
Anticipated trial start date
2013 Year 02 Month 07 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 04 Month 10 Day

Other
Other related information case control
retrospective
consecutive cases

Management information
Registered date
2013 Year 06 Month 11 Day
Last modified on
2013 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012785

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.