UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054068 |
|---|---|
| Receipt number | R000061733 |
| Scientific Title | A study on small bowel scrutiny in diarrhoea associated with the administration of immune checkpoint inhibitors. |
| Date of disclosure of the study information | 2024/04/05 |
| Last modified on | 2024/04/04 23:36:49 |
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Basic information
Public title
A study on small bowel scrutiny in diarrhoea associated with the administration of immune checkpoint inhibitors.
Acronym
A study on small bowel scrutiny in diarrhoea associated with the administration of immune checkpoint inhibitors.
Scientific Title
A study on small bowel scrutiny in diarrhoea associated with the administration of immune checkpoint inhibitors.
Scientific Title:Acronym
A study on small bowel scrutiny in diarrhoea associated with the administration of immune checkpoint inhibitors.
Region
| Japan |
Condition
Condition
Diarrhoea associated with administration of immune checkpoint inhibitors
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To investigate mucosal changes in the small intestine in patients with diarrhoea associated with the administration of immune checkpoint inhibitors.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of small bowel capsule endoscopy.
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
1) Patients with suspected diarrhoea associated with ICI administration
2) Patients for whom small bowel capsule endoscopy is (or was) performed for the purpose of ICI scrutiny.
3) Men and women aged 18 years and over at the time of small bowel capsule endoscopy.
Key exclusion criteria
(1) Patients who have refused to participate in response to the opt-out.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Misawa |
| Middle name | |
| Last name | Noboru |
Organization
Yokohama City University Hospital
Division name
Endoscopy centre
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
0457872800
nobomisa@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Misawa |
| Middle name | |
| Last name | Noboru |
Organization
Yokohama City University Hospital
Division name
Endoscopy centre
Zip code
247-0006
Address
3-9, Fukuura, Kanazawa-ku, Yokohama
TEL
09061961466
Homepage URL
nobomisa@hotmail.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
Yokohama City University Hospital
Address
s
Tel
0457872800
nobomisa@hotmail.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 05 | 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
| 2023 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None in particular.
Management information
Registered date
| 2024 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061733
