UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042890 |
|---|---|
| Receipt number | 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 22:14:08 |
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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
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
masekigu@ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048956
