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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014643
Receipt No. R000015780
Scientific Title Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Date of disclosure of the study information 2014/07/24
Last modified on 2019/01/27

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Basic information
Public title Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Acronym Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Scientific Title Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Scientific Title:Acronym Study of false negative lesions in mucosal sites of the head and neck in the preoperative evaluation of transoral endoscopy with the NBI
Region
Japan

Condition
Condition Pharyngeal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the frequency of false negative lesions in the preoperative evaluation of transoral endoscopy with the NBI for patients with pharyngeal cancer
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To investigate the rate of false negative lesions between preoperative examination and lugol chromoendoscopy using curved laryngoscope in surgery
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (i) no evidence of invasion to the muscle layer on the basis of white light endoscopy.
(ii) no lymph node metastasis as shown on computed tomographic examinations before treatment.
(iii) a histological diagnosis of squamous cell carcinoma,
(iv) an Eastern Cooperative Oncology Group performance status (ECOG PS) score of 0-2
(v) adequate major organ functions
(vi) serious complications such as active infectious disease and serious heart disease.
Key exclusion criteria Psychiatric disease that is inappropriate for entry into this study
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hisashi Doyama
Organization Ishikawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL 076-237-8211
Email doyama.134@ipch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Tsuji
Organization Ishikawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address 2-1 Kuratukihigashi, Kanazawa-shi, Ishikawa
TEL 076-237-8211
Homepage URL
Email kt98052@yahoo.co.jp

Sponsor
Institute Department of Gastroenterology, Ishikawa Prefectural Central Hospital
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
2014 Year 07 Month 24 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
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
2014 Year 02 Month 03 Day
Date of IRB
Anticipated trial start date
2014 Year 07 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The aim of this study was to evaluate the false negative pharyngeal cancers in the preoperative endoscopic examination.

Management information
Registered date
2014 Year 07 Month 24 Day
Last modified on
2019 Year 01 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015780

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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