UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055809 |
|---|---|
| Receipt number | R000063788 |
| Scientific Title | Evaluation of the Endoscopic Diagnostic Accuracy for Intestinal Transplant-Associated Microangiopathy (iTAM) |
| Date of disclosure of the study information | 2024/10/15 |
| Last modified on | 2024/10/11 14:40:29 |
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Basic information
Public title
Evaluation of the Endoscopic Diagnostic Accuracy for Intestinal Transplant-Associated Microangiopathy (iTAM)
Acronym
Evaluation of the Endoscopic Diagnostic Accuracy for Intestinal Transplant-Associated Microangiopathy (iTAM)
Scientific Title
Evaluation of the Endoscopic Diagnostic Accuracy for Intestinal Transplant-Associated Microangiopathy (iTAM)
Scientific Title:Acronym
Evaluation of the Endoscopic Diagnostic Accuracy for Intestinal Transplant-Associated Microangiopathy (iTAM)
Region
| Japan |
Condition
Condition
Patients after hematopoietic stem cell transplantation
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether endoscopic findings in patients scheduled for endoscopy (either upper gastrointestinal endoscopy or colonoscopy) correspond to the pathological findings of intestinal transplant-associated microangiopathy (iTAM)
Basic objectives2
Others
Basic objectives -Others
Diagnostic capability
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
As part of clinical practice during endoscopic procedures (upper gastrointestinal endoscopy or colonoscopy), biopsy and pathological diagnosis are performed. Endoscopic findings are compared with histopathological findings to investigate their correlation.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients after hematopoietic stem cell transplantation scheduled to undergo endoscopy (gastroscopy or colonoscopy)
Key exclusion criteria
Women who are pregnant or may become pregnant
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8557
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
pr145h2k@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku
TEL
0862357219
Homepage URL
pr145h2k@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Masaya Iwamuro
Funding Source
Organization
Okayama University Hospital
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
Okayama University IRB
Address
2-5-1 Shikata-cho, Kita-ku
Tel
0862357219
pr145h2k@okayama-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 | 10 | Month | 15 | 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
| 2024 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 10 | Month | 11 | Day |
Last modified on
| 2024 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063788
