UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013917
Receipt number R000016229
Scientific Title Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.
Date of disclosure of the study information 2014/05/10
Last modified on 2022/11/14 18:49:00

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Basic information

Public title

Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.

Acronym

Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.

Scientific Title

Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.

Scientific Title:Acronym

Prospective study for endocytoscopy-based computer-aided diagnosis system for small colorectal lesions.

Region

Japan


Condition

Condition

Small colorectal polyps

Classification by specialty

Gastroenterology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

To prospectively evaluate the usefulness of endocytoscopy-based computer-aided diagnosis system.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Diagnostic abilities for detecting neoplastic change of small polyps;sensitivity, specificity, accuracy, positive predictive value, and negative predictive value

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Diagnosis by endoscopists

Interventions/Control_2

Diagnosis with use of the endocytoscopy-based computer-aided diagnosis system

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

Patients who undergo colonoscopy and detected of a small polyp (=<10mm) whose histology is unknown.

Key exclusion criteria

Inflamatory bowel disease
Patients from whom clear endoscopic images are difficult to obtain

Target sample size

270


Research contact person

Name of lead principal investigator

1st name Yuichi
Middle name
Last name Mori

Organization

Showa University Northern Yokohama Hospital

Division name

Digestive Disease Center

Zip code

224-8503

Address

35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama

TEL

045-949-7693

Email

ibusiginjp@hotmail.com


Public contact

Name of contact person

1st name Yuichi
Middle name
Last name Mori

Organization

Showa University Northen Yokohama Hospital

Division name

Digestive Disease Center

Zip code

2248503

Address

35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama

TEL

045-949-7693

Homepage URL


Email

ibusiginjp@hotmail.com


Sponsor or person

Institute

Digestive Disease Center, Showa University Northern Yokohama Hospital

Institute

Department

Personal name



Funding Source

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Showa University Northern Yokohama Hospital; Regonale Komiteer For Medisinsk Og Helsefaglig Forskningsetikk

Address

35-1, Chigasaki-tyuo, Tsuzuki-ku, Yokohama; Gullhaugveien 1-3, 0484 Oslo

Tel

+81459497000

Email

irb02syh@ofc.showa-u.ac.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

昭和大学横浜市北部病院消化器センター(神奈川県)
Digestive Disease Center, Showa University Northern Yokohama Hospital (Kanagawa)


Other administrative information

Date of disclosure of the study information

2014 Year 05 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 02 Month 01 Day

Date of IRB

2014 Year 02 Month 28 Day

Anticipated trial start date

2017 Year 01 Month 01 Day

Last follow-up date

2024 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 05 Month 09 Day

Last modified on

2022 Year 11 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016229


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name