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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042432
Receipt No. 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 2020/11/17

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

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

Other administrative information
Date of disclosure of the study information
2020 Year 11 Month 12 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
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 10 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
2020 Year 11 Month 12 Day
Last modified on
2020 Year 11 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048064

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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