UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014643 |
|---|---|
| Receipt number | 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 21:04:02 |
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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
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
kt98052@yahoo.co.jp
Sponsor or person
Institute
Department of Gastroenterology, Ishikawa Prefectural Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015780
