UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060702 |
|---|---|
| Receipt number | R000069439 |
| Scientific Title | Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination |
| Date of disclosure of the study information | 2026/02/18 |
| Last modified on | 2026/02/18 16:06:01 |
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Basic information
Public title
Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination
Acronym
Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination
Scientific Title
Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination
Scientific Title:Acronym
Molecular Pathological Analysis of Biopsy and Autopsy Specimens from Patients Who Developed Adverse Events following COVID-19 Infection and/or COVID-19 Vaccination
Region
| Japan |
Condition
Condition
Adverse events following COVID-19 infection and/or COVID-19 vaccination
Classification by specialty
| Medicine in general |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the molecular pathogenesis by detecting residual vaccine-derived nucleic acids or proteins using histological and molecular biological methods in cases that developed adverse events after COVID-19 infection and/or COVID-19 vaccination and underwent biopsy, as well as in fatal cases with sequelae that underwent autopsy.
Basic objectives2
Others
Basic objectives -Others
Elucidation of immunopathological and molecular biological pathogenesis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Not applicable because the primary outcome is immunopathological and molecular biological analyses on an individual case basis.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patients who have provided written informed consent form by signing a consent form to participate in this research. In case of deceased subjects, informed consent will be obtained from a legally authorized representative.
2.Patients who have developed adverse events after COVID-19 infection and/or COVID-19 vaccination, or after blood transfusion from a donor who has received a COVID-19 vaccine.
3.Patients who have specimens collected and stored during routine clinical practice or specimens preserved by autopsy; patients who are able to provide blood samples or biopsy specimens collected in addition to routine clinical practice, or surgical specimens obtained during routine clinical practice; or patients who are able to newly provide urine or sweat samples.
4.No upper or lower age limit is set.
Key exclusion criteria
None.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Shigetoshi |
| Middle name | |
| Last name | Sano |
Organization
Sano Dermatology Office
Division name
NA
Zip code
663-8184
Address
1-19-13 Naruocho, Nishinomiya-city, Hyogo, 663-8184, Japan
TEL
0798-40-7272
sano.derma@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichiro |
| Middle name | |
| Last name | Kodama |
Organization
Japanese Society for Vaccine-related Complications
Division name
NA
Zip code
665-0842
Address
#205, 5-10-32 Kawamo, Takarazuka, Hyogo, 665-0842, Japan
TEL
0797-86-1313
Homepage URL
info@jsvrc.jp
Sponsor or person
Institute
Japanese Society for Vaccine-related Complications
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
Ethics Committee of Hamamatsu University School of Medicine (EC HUSM)
Address
1-20-1, Handayama, Higashi-ku, Hamamatsu 431-3192, Japan
Tel
053-435-2680
rinri@hama-med.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
医療法人社団それいゆ会 こだま病院・児玉診療所(兵庫県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 02 | Month | 18 | 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
| 2026 | Year | 02 | Month | 06 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
- Research design: Molecular pathological and histological examination of biopsy and autopsy specimens
- Method of recruitment:
Patients who visited research implementing entity or were referred to research implementing entity from other medical institutions between February 2020 and December 31, 2026, and who meet the inclusion criteria and are judged by their attending physician to be appropriate for participation in this research, will be registered as research subjects. In addition, existing specimens and information may be provided from institutions which only provide existing specimens and information.
At affiliated institutions of the Japanese Society for Vaccine-related Complications, some research subjects have already been identified.
- To link the following datasets and explore potential associations and possible causal relationships from a molecular pathological perspective.:
1.Patient background
2.COVID-19 infection history
3.Information on adverse events that occurred after COVID-19 infection/COVID-19 vaccination/blood transfusion from vaccinated donors
4.Specimen information
5.Polymerase Chain Reaction (PCR)
6.Immunohistochemistry, Immunocytochemistry, Immunofluorescence
7.Whole Genome Sequencing
8.RNA Sequencing
9.Single Cell RNA Sequencing
Management information
Registered date
| 2026 | Year | 02 | Month | 18 | Day |
Last modified on
| 2026 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069439
