UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055982 |
|---|---|
| Receipt number | R000063700 |
| Scientific Title | Examination of the positive rate of fecal occult blood test and factors related to negative fecal occult blood test in patients with lesions suitable for colorectal endoscopic submucosal dissection |
| Date of disclosure of the study information | 2024/10/31 |
| Last modified on | 2024/11/06 22:12:44 |
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Basic information
Public title
Examination of the positive rate of fecal occult blood test and factors related to negative fecal occult blood test in patients with lesions suitable for colorectal endoscopic submucosal dissection
Acronym
Examination of the positive rate of fecal occult blood test in patients with lesions suitable for colorectal endoscopic submucosal dissection
Scientific Title
Examination of the positive rate of fecal occult blood test and factors related to negative fecal occult blood test in patients with lesions suitable for colorectal endoscopic submucosal dissection
Scientific Title:Acronym
Examination of the positive rate of fecal occult blood test in patients with lesions suitable for colorectal endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
colorectal neoplasms
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validation of positive rate of fecal occult blood test in patients with lesions suitable for colorectal endoscopic submucosal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Positive rate of fecal occult blood test before colorectal endoscopic submucosal dissection
Key secondary outcomes
Characteristics of lesions that are likely to result in positive/negative fecal occult blood in stool
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
Prevention
Type of intervention
| Other |
Interventions/Control_1
Fecal occult blood test
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with lesions suitable for colorectal endoscopic submucosal dissection will be consecutively enrolled in the present study
Key exclusion criteria
Patients have another advanced colorectal cancer
Patients with two or more lesions suitable for ESD
Patients with inflammatory bowel disease
Patients in disagreement with informed consent
Other cases where the principal investigator considers patients to be inappropriate
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1 Chuou Ohta-ku, Tokyo, Japan
TEL
+81-3-3775-3111
junarimoto_junjun@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Arimoto |
Organization
Omori Red Cross Hospital
Division name
Department of Gastroenterology
Zip code
143-8527
Address
4-30-1 Chuou Ohta-ku, Tokyo, Japan
TEL
+81-3-3775-3111
Homepage URL
junarimoto_junjun@yahoo.co.jp
Sponsor or person
Institute
Omori Red Cross Hospital
Institute
Department
Personal name
Jun Arimoto
Funding Source
Organization
This study do not need financial support
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
Omori Red Cross Hospital
Address
4-30-1 Chuou Ohta-ku, Tokyo, Japan
Tel
+81-3-3775-3111
junarimoto_junjun@yahoo.co.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
大森赤十字病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 10 | Month | 31 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2026 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2026 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2026 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 10 | Month | 29 | Day |
Last modified on
| 2024 | Year | 11 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063700
