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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042890
Receipt No. R000048956
Scientific Title Multicenter prospective study of colorectal serrated lesions in the Asia-Pacific region
Date of disclosure of the study information 2021/01/04
Last modified on 2021/01/03

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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

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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