UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037897 |
|---|---|
| Receipt number | R000043200 |
| Scientific Title | Feasibility of cytomegalovirus antigenemia test in the endoscopically-biopsied gastrointestinal mucosa |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2023/03/06 11:33:18 |
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Basic information
Public title
Feasibility of cytomegalovirus antigenemia test in the endoscopically-biopsied gastrointestinal mucosa
Acronym
Cytomegalovirus antigenemia test and endoscopic biopsy
Scientific Title
Feasibility of cytomegalovirus antigenemia test in the endoscopically-biopsied gastrointestinal mucosa
Scientific Title:Acronym
Cytomegalovirus antigenemia test and endoscopic biopsy
Region
| Japan |
Condition
Condition
Gastrointestinal cytomegalovirus infection
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether CMV antigenemia test can be performed on the endoscopically-biopsied gastrointestinal mucosa
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To compare immunostaining results (histological diagnosis) of patients with gastrointestinal CMV infection and CMV antigenemia analysis results of the endoscopically-biopsed tissues
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with clinically suspected gastrointestinal CMV infection who are scheduled to undergo endoscopy and endoscopic biopsy
Key exclusion criteria
Women who are pregnant or may be pregnant
Target sample size
10
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
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
iwamuromasaya@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Masaya |
| Middle name | |
| Last name | Iwamuro |
Organization
Okayama University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
0862357218
Homepage URL
iwamuromasaya@yahoo.co.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology and Hepatology, 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 Hospital
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
Tel
0862357218
MAE6605@adm.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
| 2019 | Year | 09 | Month | 02 | Day |
Related information
URL releasing protocol
http://www.okayama-gastro.com/common/file/patient/file/202303061018150882939.pdf
Publication of results
Unpublished
Result
URL related to results and publications
http://www.okayama-gastro.com/common/file/patient/file/202303061018150882939.pdf
Number of participants that the trial has enrolled
6
Results
We have enrolled a cohort of six patients, and our testing procedures detected no instances of CMV positivity among the participants.
Results date posted
| 2023 | Year | 03 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We have recruited patients who exhibited clinical symptoms indicative of CMV infection in the gastrointestinal tract.
Participant flow
Lymphocytes were extracted from the digestive mucosal biopsy specimen, following which the CMV antigenemia assay was performed to identify the presence of CMV infection. Subsequently, the obtained results were cross-examined with the immunostaining findings.
Adverse events
None
Outcome measures
CMV antigenemia assay on the digestive mucosal biopsy specimen
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 06 | Month | 23 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 09 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 31 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Observational study
Management information
Registered date
| 2019 | Year | 09 | Month | 02 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043200
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
