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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000016473
Receipt No. R000018411
Scientific Title Long-term follow-up study for the microlesions of the pharynx and esophagus detected by narrow-band imaging (NBI).
Date of disclosure of the study information 2015/02/10
Last modified on 2015/03/21

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Basic information
Public title Long-term follow-up study for the microlesions of the pharynx and esophagus detected by narrow-band imaging (NBI).
Acronym Long-term follow-up for the microlesions of the pharynx and esophagus detected by NBI.
Scientific Title Long-term follow-up study for the microlesions of the pharynx and esophagus detected by narrow-band imaging (NBI).
Scientific Title:Acronym Long-term follow-up for the microlesions of the pharynx and esophagus detected by NBI.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the natural history of the microlesions of the pharynx and esophagus and to establish the treatment strategy of these lesions.
Basic objectives2 Others
Basic objectives -Others To evaluate the incidence of carcinoma derived from the microlesions of the pharynx and esophagus.
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The incidence of carcinoma derived from the microlesions of the pharynx and esophagus.
Key secondary outcomes The progression of the microlesions of the pharynx and esophagus.
Relationship with drinking or smoking or family history.

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 Patients diagnosed as having microlesions of the pharynx and esophagus detected by NBI.
Key exclusion criteria 1)Patients taking medication that might interfere with the collection of a biopsy.
2)considered ineligible by attendant doctors.
Target sample size 50

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 Kuratsukihigashi 2-1, Kanazawa-shi, Ishikawa
TEL 076-237-8211
Email doyama.134@ipch.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyoshi Nakanishi
Organization Ishikawa Prefectural Central Hospital
Division name Department of Gastroenterology
Zip code
Address Kuratsukihigashi 2-1, Kanazawa-shi, Ishikawa
TEL 076-237-8211
Homepage URL
Email nakanishi@ipch.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 石川県立中央病院(石川県)

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 10 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 Open public recruiting
Date of protocol fixation
2014 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 01 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Prospective observational study

Management information
Registered date
2015 Year 02 Month 08 Day
Last modified on
2015 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018411

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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