UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033317 |
|---|---|
| Receipt number | R000037980 |
| Scientific Title | Efficacy and Safety of Cold Forceps Biopsy for Diminutive Pharyngolaryngeal Neoplasms |
| Date of disclosure of the study information | 2018/07/07 |
| Last modified on | 2020/03/13 20:55:29 |
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Basic information
Public title
Efficacy and Safety of Cold Forceps Biopsy for
Diminutive Pharyngolaryngeal Neoplasms
Acronym
CFB-PLANS trial
Scientific Title
Efficacy and Safety of Cold Forceps Biopsy for
Diminutive Pharyngolaryngeal Neoplasms
Scientific Title:Acronym
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 recurrence rate 3 months after treatment
Key secondary outcomes
Complete resection rate, Pathological local recurrence rate 3 months after treatment, Endoscopic and Pathological local recurrence rate 12
months and 36 months after treatment, The rate of perioperative and postoperative bleeding
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
| 1st name | |
| Middle name | |
| Last name | Yuichi Shimodate |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
ys13544@kchnet.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuichi Shimodate |
Organization
Kurashiki Central Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-1-1, Miwa, Kurashiki, Okayama, Japan
TEL
0864220210
Homepage URL
ys13544@kchnet.or.jp
Sponsor or person
Institute
Kurashiki Central Hospital
Institute
Department
Personal name
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)
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
| 2018 | Year | 07 | Month | 07 | 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
| 2018 | Year | 06 | Month | 27 | Day |
Date of IRB
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
Other
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
| 2020 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037980
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
