UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061153 |
|---|---|
| Receipt number | R000068610 |
| Scientific Title | Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study. |
| Date of disclosure of the study information | 2026/05/01 |
| Last modified on | 2026/04/03 15:05:13 |
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Basic information
Public title
Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study.
Acronym
Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study.
Scientific Title
Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study.
Scientific Title:Acronym
Evaluating the Diagnostic Accuracy and Safety of Endoscopic Ultrasound (EUS) Using a Gel for Early Colorectal Cancer Staging: A Multicenter Prospective Observational Study.
Region
| Japan |
Condition
Condition
Early Colorectal Cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Objectives The primary objective of this study is to evaluate the diagnostic accuracy and safety of endoscopic ultrasonography (EUS) for determining the invasion depth in early colorectal cancer, utilizing a viscous, colorless, and transparent endoscopic field-of-view securing gel as a substitute for water to distend the gastrointestinal lumen.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Specificity for the differential diagnosis of cTis, cT1.
Key secondary outcomes
Accuracy, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) for the diagnosis of cTis, cT1.
Accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for diagnosing a VM (distance from the tumor invasion front to the muscularis propria) of >= 500 um in endoscopically or surgically resected specimens, based on the Tumor-free distance (EUS-TFD) classification (Type I: EUS-TFD >= 1 mm vs. Type II: EUS-TFD < 1 mm).
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Selection (Inclusion) Criteria: Patients must meet all of the following criteria:
(1) Colorectal neoplastic lesions diagnosed as JNET Type 2B. (2) Lesions measuring 5 to 30 mm in diameter. (3) Patients expected to undergo endoscopic or surgical treatment within 3 months after the Gel-EUS examination. (4) Patients aged 20 to 90 years at the time of informed consent acquisition. (5) Patients with a Performance Status (PS; ECOG) of 0, 1, or 2. (6) Gender is not a factor (Irrespective of gender). (7) Patients who have provided voluntary written informed consent from themselves or a legally acceptable representative.
Key exclusion criteria
Patients who meet any of the following criteria will not be included in this study:
(1) Lesions diagnosed as cT2 cancer or deeper on conventional and magnifying endoscopic observation. (2) Lesions diagnosed as an adenoma on conventional and magnifying endoscopic observation. (3) Lesions with a macroscopic type of 0-Ip (pedunculated type). (4) Residual or recurrent lesions after prior endoscopic treatment. (5) Patients with a complication or history of inflammatory bowel disease (IBD). (6) Patients with colonic polyposis. (7) Females who are pregnant or have the potential to become pregnant. (8) Patients who have a history of prior registration in this study. (9) Cases judged to be inappropriate for participation in this study by the Principal Investigator or Sub-investigator.
Target sample size
134
Research contact person
Name of lead principal investigator
| 1st name | Shiro |
| Middle name | |
| Last name | Oka |
Organization
Hiroshima University Hospital
Division name
Department of Gastroenterology
Zip code
734-8551
Address
1-2-3, Kasumi, Minamiku, Hiroshima, Japan
TEL
082-257-5190
oka4683@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshio |
| Middle name | |
| Last name | Kuwai |
Organization
Hiroshima University Hospital
Division name
Gastrointestinal Endoscopy and Medicine
Zip code
734-8551
Address
1-2-3, Kasumi, Minamiku, Hiroshima, Japan
TEL
082-257-5193
Homepage URL
kuwai@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University Hospital
Institute
Department
Personal name
Funding Source
Organization
none
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
Hiroshima University hospital IRB, Hiroshima, Japan
Address
1-2-3, Kasumi, Minamiku, Hiroshima, Japan
Tel
082-257-5190
iryo-sinsa@office.hiroshima-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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 01 | 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
| 2026 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Before starting
Management information
Registered date
| 2026 | Year | 04 | Month | 03 | Day |
Last modified on
| 2026 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068610
