UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042432
Receipt number R000048064
Scientific Title Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)
Date of disclosure of the study information 2020/11/12
Last modified on 2022/11/01 11:59:51

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Basic information

Public title

Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)

Acronym

Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)

Scientific Title

Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)

Scientific Title:Acronym

Asian randomized control trial for the efficacy of linked color imaging system for adenoma and polyp detection rates in screening or surveillance colonoscopy (ATLAS trial)

Region

Japan Asia(except Japan)


Condition

Condition

Colorectal adenoma or polyp

Classification by specialty

Gastroenterology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to evaluate whether LCI is superior to the conventional white light image in terms of adenoma detection rate (ADR) in screening or surveillance colonoscopy.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase III


Assessment

Primary outcomes

The primary outcome is the ADR, defined as the proportion of participants with at least one adenoma (per-patient analysis), between LCI and white light image groups.

Key secondary outcomes

1. The polyp detection rate (PDR), defined as the proportion of participants with at least one polyp at a per-patient analysis.
2. The advanced ADR, defined as the proportion of participants with at least one advanced adenoma at a per-patient analysis.
3. The SSL-DR, defined as the proportion of participants with at least one SSL at a per-patient analysis.
4. The proximal ADR, defined as the proportion of participants with at least one adenoma at the proximal colon (cecum to transverse colon) at a per-patient analysis.
5. The mean number of adenomas per patient.
6. The mean number of polyps per patient.
7. The mean number of advanced adenomas per patient.
8. The mean number of SSLs per patient.
9. mean number of proximal adenomas per patient
10. The adenoma or polyp detection rate according to clinicopathological characteristics of the lesions.
11. The adenoma or polyp detection rate according to the experience of colonoscopists.
12. The adenoma or polyp detection rate with or without sedation.
13. The adenoma or polyp detection rate with or without antispasmodics.
14. The adenoma or polyp detection rate according to the endoscopic system (laser system or LED system).
15. The adenoma or polyp detection rate according to the bowel preparation scale.
16. The adenoma or polyp detection rate according to observation time.
17. Adverse event rates.


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

YES

Dynamic allocation

YES

Institution consideration

Institution is considered as adjustment factor in dynamic allocation.

Blocking

NO

Concealment

Central registration


Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Whole colonic mucosa is observed by the linked color imaging (LCI).

Interventions/Control_2

Whole colonic mucosa is observed by white light imaging (WLI).

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

40 years-old <=

Age-upper limit

89 years-old >=

Gender

Male and Female

Key inclusion criteria

1. Patients who will undergo colonoscopy
2. Age of 40-89 years
3. Performance status (ECOG) 0, 1, or 2
4. Written informed consent

Key exclusion criteria

1. History of colorectal surgery (The only appendectomy is acceptable)
2. Known inflammatory bowel disease
3. Known hereditary or non- hereditary polyposis syndrome
4. Known hereditary non-polyposis colorectal cancer (HNPCC)
5. Known severe diverticular segment which restricts total colonoscopy
6. Cannot stop antiplatelet or anticoagulant drugs during colonoscopy
7. Allergy to any drugs used during colonoscopy
8. Known colorectal adenoma, polyp, or cancer before the trial
9. Pregnancy
10. Breast-feeding
11. Lack of informed consent
12. Others

Target sample size

3000


Research contact person

Name of lead principal investigator

1st name Takuji
Middle name
Last name Gotoda

Organization

Nihon University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Medicine

Zip code

101-8309

Address

1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan

TEL

03-3293-1711

Email

takujigotoda@yahoo.co.jp


Public contact

Name of contact person

1st name Sho
Middle name
Last name Suzuki

Organization

Nihon University School of Medicine

Division name

Division of Gastroenterology and Hepatology, Department of Medicine

Zip code

101-8309

Address

1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan

TEL

03-3293-1711

Homepage URL


Email

s.sho.salubriter.mail@gmail.com


Sponsor or person

Institute

Division of Gastroenterology and Hepatology, Department of Medicine,Nihon University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Nihon University School of Medicine

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

Institutional Review Board of Nihon University Hospital

Address

1-6 Kanda-Surugadai, Chiyoda-ku, Tokyo, Japan

Tel

03-3293-1711

Email

nuhosp.rinri@nihon-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

Nihon University School of Medicine, Nagoya University Graduate School of Medicine, Kyoto Prefectural University of Medicine, Jichi Medical University, Yuri Kumiai General Hospital, SingHealth (Changi General Hospital), Tan Tock Seng HP, National Taiwan University Hospital Cancer Center, Rajavithi hospital, Chulalongkorn University, Phramongkutklao Hospital, College of Medicine, Fu Jen Catholic University Hospital, Korea University Ansan Hospital.


Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://www.cghjournal.org/article/S1542-3565(22)01010-2/fulltext

Number of participants that the trial has enrolled

3050

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

Completed

Date of protocol fixation

2020 Year 10 Month 11 Day

Date of IRB

2020 Year 11 Month 12 Day

Anticipated trial start date

2020 Year 11 Month 17 Day

Last follow-up date

2022 Year 01 Month 31 Day

Date of closure to data entry

2022 Year 03 Month 28 Day

Date trial data considered complete

2022 Year 03 Month 28 Day

Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 12 Day

Last modified on

2022 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048064


Research Plan
Registered date File name
2022/03/28 Protocol_ATLAS trial.pdf

Research case data specifications
Registered date File name

Research case data
Registered date File name
2022/09/16 ATLAS data (Sep 6, 2022).xlsx