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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000045621
Receipt No. R000052085
Scientific Title A single-center prospective study to evaluate the diagnostic performance of NBI magnification under acetic acid spraying for colorectal tumors
Date of disclosure of the study information 2021/10/02
Last modified on 2021/09/30

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Basic information
Public title Usefulness of acetic acid NBI magnification endoscopy for colorectal tumors
Acronym Usefulness of acetic acid NBI magnification endoscopy for colorectal tumors(ANBI colon study)
Scientific Title A single-center prospective study to evaluate the diagnostic performance of NBI magnification under acetic acid spraying for colorectal tumors
Scientific Title:Acronym A single-center prospective study to evaluate the diagnostic performance of NBI magnified endoscopy under acetic acid spraying for colorectal tumors(ANBI colon study)
Region
Japan

Condition
Condition Colorectal tumor diagnosed as JNET classification 2B by NBI magnified endoscopic observation
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Equivalence of the diagnostic performance of NBI magnification under acetic acid spraying to that of crystal violet stained magnification endoscopy for the diagnosis of pit patterns
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Inter-methodological diagnostic agreement and inter-observer diagnostic agreement between NBI magnification endoscopic pit pattern diagnosis under acetic acid spraying and crystal violet stained magnification endoscopic pit pattern diagnosis of colorectal neoplasm
Key secondary outcomes Results of pit pattern diagnosis by NBI under acetic acid spraying magnifying endoscopy and crystal violet-stained magnifying endoscopy , examination of findings specific to SM-d lesions as exploratory items, and adverse events.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 NBI magnified endoscopic observation under 4.5 %acetic acid spraying, Crystal violet stained magnified endoscopic observation
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria a. Patients who are 18 years of age or older and who have received sufficient explanation and written consent for this study.
b. Patients who have a colorectal tumor requiring treatment by colonoscopy and diagnosed as JNET 2B by NBI magnification.
c. Patients who underwent NBI magnification under acetic acid spraying and crystal violet staining magnification of the region of interest, with the region diagnosed as JNET 2B as the region of interest, and both photographs were taken to show a well-focused pit pattern.
Key exclusion criteria a. Recurrent lesions left over from endoscopic treatment
b. Patients who have received systemic chemotherapy within 6 months prior to endoscopic examination.
c. Patients with a history of radiation therapy to the abdominal pelvis.
d. Patients with a history of ulcerative colitis.
e. Patients who have been diagnosed with familial adenomatous polyposis.
f. Those who are pregnant or may become pregnant.
g. Those who are judged unsuitable by the doctor in charge.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name Takeshi
Middle name
Last name Shimizu
Organization Sendai City Medical Center Sendai Open Hospital
Division name Gastroenterology
Zip code 9830824
Address Tsurugaya 5-22-1, Miyagino, Sendai, Miyagi, Japan
TEL 022-252-1111
Email takeshi.shimizu@openhp.or.jp

Public contact
Name of contact person
1st name Takeshi
Middle name
Last name Shimizu
Organization Sendai City Medical Center Sendai Open Hospital
Division name Gastroenterology
Zip code 9830824
Address Tsurugaya 5-22-1, Miyagino, Sendai, Miyagi, Japan
TEL 022-252-1111
Homepage URL
Email takeshi.shimizu@openhp.or.jp

Sponsor
Institute Sendai City Medical Center Sendai Open Hospital Department of Gastroenterology
Institute
Department

Funding Source
Organization Sendai City Medical Center Sendai Open Hospital Department of Gastroenterology
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 Sendai City Medical Center Sendai Open Hospital
Address Tsurugaya 5-22-1, Miyagino, Sendai, Miyagi, Japan
Tel 0222521111
Email takeshi.shimizu@openhp.or.jp

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
2021 Year 10 Month 02 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 Enrolling by invitation
Date of protocol fixation
2021 Year 08 Month 08 Day
Date of IRB
2021 Year 08 Month 19 Day
Anticipated trial start date
2021 Year 10 Month 01 Day
Last follow-up date
2024 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 09 Month 30 Day
Last modified on
2021 Year 09 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052085

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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