UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045456
Receipt number R000051899
Scientific Title Confirm that cOlon Neoplasm Finely can be IDENTIfied by AI without overLooking; CONFIDENTIAL study
Date of disclosure of the study information 2021/09/11
Last modified on 2023/03/14 12:02:10

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Confirm that cOlon Neoplasm Finely can be IDENTIfied by AI without overLooking; CONFIDENTIAL study

Acronym

CONFIDENTIAL study

Scientific Title

Confirm that cOlon Neoplasm Finely can be IDENTIfied by AI without overLooking; CONFIDENTIAL study

Scientific Title:Acronym

CONFIDENTIAL study

Region

Japan


Condition

Condition

Suspected colorectal tumor (including colorectal adenoma)

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify how much colorectal adenoma detection has an additional effect on normal screening examinations using a colonoscopy equipped with AI function.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison of overall adenoma lesion detection rate (ADR) between endoscopists and Artificial Intelligence

Key secondary outcomes

(1) Comparison of the number of adenomas per case (adenomas / number of cases) between endoscopists and Artificial Intelligence
(2) Comparison of ADR between specialists and non-specialists (including residents)
(3) Comparison of the number of adenomas per case between specialists and non-specialists (including residents)


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

100 years-old >=

Gender

Male and Female

Key inclusion criteria

(1) Patients who undergo colonoscopy without a history of colonoscopy for more than 3 years at the research facility
(2) Patients who can perform preparation as usual

Key exclusion criteria

(1) Emergency endoscopy case
(2) Patients with a history of colectomy or severe adhesions of colon are known in advance
(3) Patients with chronic bowel disease such as inflammatory bowel disease
(4) Patients with poor preparation
(5) Patients judged inappropriate by the doctor in charge of this study

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kazuhiro
Middle name
Last name Mizukami

Organization

Oita University, Faculty of medicine

Division name

Department of Gastroenterology

Zip code

879-5593

Address

1-1, idaigaoka, Hasama, Yufu, Oita

TEL

097-586-6193

Email

mizkaz0809@oita-u.ac.jp


Public contact

Name of contact person

1st name Kazuhiro
Middle name
Last name Mizukami

Organization

Oita University, Faculty of medicine

Division name

Department of Gastroenterology

Zip code

879-5593

Address

1-1, idaigaoka, Hasama, Yufu, Oita

TEL

097-586-6193

Homepage URL


Email

mizkaz0809@oita-u.ac.jp


Sponsor or person

Institute

Oita University

Institute

Department

Personal name



Funding Source

Organization

Department of Gatroenterology, Faculty of medicine, Oita University

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

Ethics Committee of Oita University, Faculty of Medicine

Address

1-1, idaigaoka, Hasama, Yufu, Oita

Tel

097-586-6380

Email

rinrikenkyu@oita-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



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 11 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

No longer recruiting

Date of protocol fixation

2021 Year 07 Month 19 Day

Date of IRB

2021 Year 09 Month 07 Day

Anticipated trial start date

2021 Year 09 Month 11 Day

Last follow-up date

2022 Year 10 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Observational study


Management information

Registered date

2021 Year 09 Month 11 Day

Last modified on

2023 Year 03 Month 14 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051899


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name