UMIN-CTR Clinical Trial

Basic information
Public title	Multicenter prospective study of colorectal serrated lesions in the Asia-Pacific region
Acronym	AP-Colon SL study
Scientific Title	Multicenter prospective study of colorectal serrated lesions in the Asia-Pacific region
Scientific Title:Acronym	AP-Colon SL study
Region	Japan Asia(except Japan)

Condition
Condition	Colorectal serrated lesion
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The prevalence, risk factors, clinical significance, and many other aspects of colorectal serrated lesions are not sufficiently understood. The main objective of this study is to examine the risk factors and clinical significance (relationships to simultaneous colorectal cancer and other colorectal lesions) of colorectal serrated lesions after clarifying the prevalence of colorectal serrated lesions, with particular focus on sessile serrated lesions (SSL) by conducting a prospective survey of individuals undergoing colorectal cancer screening at multiple centers in the Asia-Pacific region.
Basic objectives2	Others
Basic objectives -Others	This study also aims to examine their clinicopathological features, the ability of endoscopy to detect and diagnose these lesions, and the usefulness of such a risk-stratification score as the Asia Pacific Colorectal Screening (APCS) score.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Colorectal SSL (sessile serrated lesion)
Key secondary outcomes	Non-SSL colorectal lesions (including non-SSL colorectal serrated lesions, colorectal cancer, advanced colorectal neoplasia, and colorectal adenoma), Serrated polyposis syndrome

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Maneuver
Interventions/Control_1	Observation of the entire proximal colon using chromoendoscopy (indigo carmine) during total colonoscopy.
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	40 years-old <=
Age-upper limit	74 years-old >=
Gender	Male and Female
Key inclusion criteria	The study participants will be average-risk individuals (age: 40-74 years) undergoing total colonoscopy (TCS) for colorectal cancer screening for the first time in their lives at the participating institutions, who will receive a full oral explanation of the study using written materials, and who will provide consent in writing. Both individuals undergoing their first TCS for screening purposes and those undergoing first TCS following a positive fecal occult blood test in colorectal cancer screening are included in this study.
Key exclusion criteria	1) Presence of uncontrollable complications, including unstable angina, acute myocardial infarction, heart failure, chronic respiratory disease, bleeding tendency, that make it difficult to safely perform TCS. 2) Clinical symptoms that indicate colorectal cancer, such as hematochezia or abdominal pain. 3) History of treatment for colorectal cancer or colorectal tumor. 4) History of colorectal surgery in which colorectum was resected. (Surgery not involving resection of colorectum such as appendectomy for appendicitis is not included in exclusion criteria) 5) Being from a family with hereditary colorectal cancer. 6) Difficult to survey baseline factors using a questionnaire. 7) Does not provide written consent. 8) Otherwise determined to be unfit by an investigator.
Target sample size	1000

Research contact person
Name of lead principal investigator	1st name Takahisa Middle name Last name Matsuda
Organization	National Cancer Center Hospital
Division name	Cancer Screening Center/ Endoscopy Division
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Email	tamatsud@ncc.go.jp

Public contact
Name of contact person	1st name Masau Middle name Last name Sekiguchi
Organization	National Cancer Center Hospital
Division name	Cancer Screening Center/ Endoscopy Division
Zip code	104-0045
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
TEL	03-3542-2511
Homepage URL
Email	masekigu@ncc.go.jp

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	Asian Novel Bio-Imaging and Intervention Group, National Cancer Center
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	the Ethics Committee for Clinical Research of the National Cancer Center, Tokyo, Japan
Address	5-1-1 Tsukiji, Chuo-ku, Tokyo, 104-0045, Japan
Tel	03-3542-2511
Email	irst@ml.res.ncc.go.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 01 Month 04 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	Preinitiation
Date of protocol fixation	2020 Year 12 Month 21 Day
Date of IRB	2020 Year 12 Month 25 Day
Anticipated trial start date	2021 Year 02 Month 01 Day
Last follow-up date	2024 Year 03 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	2021 Year 01 Month 03 Day
Last modified on	2021 Year 01 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048956