UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054451 |
|---|---|
| Receipt number | R000062194 |
| Scientific Title | Endoscopic Prediction and Optical evaluation with CHromoendoscopy using acetic acid for colonic lesions |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2025/05/17 10:39:38 |
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Basic information
Public title
Endoscopic Prediction and Optical evaluation with CHromoendoscopy using acetic acid for colonic lesions
Acronym
EPOCH trial
Scientific Title
Endoscopic Prediction and Optical evaluation with CHromoendoscopy using acetic acid for colonic lesions
Scientific Title:Acronym
EPOCH trial
Region
| Japan |
Condition
Condition
Colorectal lesions with morphological type Paris 0 and 10mm or larger in size which endoscopic or surgical treatment is planned
Classification by specialty
| Gastroenterology | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To analyze the efficacy of pre-treatment assessment with acetoelectronic endoscopy for colorectal neoplastic lesions
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of pre-treatment endoscopic in comparison with post-treatment pathological diagnosis
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with colorectal lesions with morphology Paris type 0 and 10mm or larger in size which is planned for endoscopic or surgical treatment
Key exclusion criteria
Patient who deny to participate in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Takehara |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
takehara@gh.med.osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yoshito |
| Middle name | |
| Last name | Hayashi |
Organization
Osaka University Graduate School of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
565-0871
Address
2-2 Yamadaoka, Suita, Osaka
TEL
06-6879-3621
Homepage URL
y.hayashi@gh.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None.
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
Department of Gastroenterology and Hepatology, Osaka University Graduate School of Medicine
Address
2-2 Yamadaoka, Suita, Osaka
Tel
06-6879-3621
y.hayashi@gh.med.osaka-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
| 2024 | Year | 08 | 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
Enrolling by invitation
Date of protocol fixation
| 2023 | Year | 06 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Performing endoscopic examination, and compare the diagnosis between pre-treatment diagnosis and post-treatment pathological diagnosis.
Management information
Registered date
| 2024 | Year | 05 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062194
