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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033317
Receipt No. R000037980
Official scientific title of the study Efficacy and Safety of Cold Forceps Biopsy for Diminutive Pharyngolaryngeal Neoplasias
Date of disclosure of the study information 2018/07/07
Last modified on 2018/08/16

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Basic information
Official scientific title of the study Efficacy and Safety of Cold Forceps Biopsy for
Diminutive Pharyngolaryngeal Neoplasias
Title of the study (Brief title) CFB-PLANS trial
Region
Japan

Condition
Condition Pharyngolaryngeal neoplasias
Classification by specialty
Gastroenterology Oto-rhino-laryngology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify efficacy and safety of cold forceps biopsy for diminutive pharyngolaryngeal neoplasias
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Endoscopic local reccurance rate 3 months after treatment
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 1. Patient with diminutive pharyngolaryngeal neoplasias diagnosed using upper endoscopy within 1 year.
2. Cessation of antithrombotic agents according to the guideline of JSGE.
3. Consent for follow-up endoscopy over 3 months after treatment.
Key exclusion criteria 1. Bleeding tendency (PLT <80000ul, PT-INR >2.5).
2. Pregnancy or breast feeding.
Target sample size 35

Research contact person
Name of lead principal investigator Yuichi Shimodate
Organization Kurashiki Central Hospital
Division name Gastroenterology and Hepatology
Address 1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL 0864220210
Email ys13544@kchnet.or.jp

Public contact
Name of contact person Yuichi Shimodate
Organization Kurashiki Central Hospital
Division name Gastroenterology and Hepatology
Address 1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL 0864220210
Homepage URL
Email ys13544@kchnet.or.jp

Sponsor
Institute Kurashiki Central Hospital
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

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
2018 Year 07 Month 07 Day

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 06 Month 27 Day
Anticipated trial start date
2018 Year 07 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information To compare local recurrence rate of 3 months and 12 months after treatment with historical data using conventional biopsy forceps

Management information
Registered date
2018 Year 07 Month 07 Day
Last modified on
2018 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037980

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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