UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050678 |
|---|---|
| Receipt number | R000057740 |
| Scientific Title | A prospective observational study on host immunity for development of novel immunotherapeutic strategy for treatment and prevention of postoperative infections |
| Date of disclosure of the study information | 2023/03/27 |
| Last modified on | 2023/03/26 15:38:42 |
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Basic information
Public title
A prospective observational study on host immunity for development of novel immunotherapeutic strategy for treatment and prevention of postoperative infections
Acronym
An observational study on immunity in patients with postoperative infections
Scientific Title
A prospective observational study on host immunity for development of novel immunotherapeutic strategy for treatment and prevention of postoperative infections
Scientific Title:Acronym
An observational study on immunity in patients with postoperative infections
Region
| Japan |
Condition
Condition
- Respiratory, digestive, and cardiovascular diseases scheduled for surgery
- Postoperative infections
Classification by specialty
| Medicine in general | Pneumology | Surgery in general |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To reveal the host immune characteristics in patients with postoperative infections
Basic objectives2
Others
Basic objectives -Others
To make recommendations/suggestions to develop strategies for treatment and prevention of postoperative infections
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1) Clinical outcome:
Onset of postoperative infections within 30 days after surgery
2) Immunological outcome:
Association between host immune characteristics and clinical outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for surgery for respiratory, gastrointestinal, cardiovascular, or other diseases.
-Age: 20 and older
Key exclusion criteria
-Patients within 1 months of recovery from an acute infection
-Patients with chronic hepatic disorders due to HBV or HCV infections.
-HIV-positive patients
-Patients previously treated with chemotherapy, immune checkpoint inhibitors, or radiation therapy for malignant tumors.
-Patients with active multiple cancers.
-Patients with active hematologic malignancies.
-Patients with hemoglobin level <= 10 g/dL.
-Patients after blood stem cell transplants, including bone marrow transplants.
-Patients treated for co-morbidities with high-dose glucocorticoid, immunosuppressive drugs, or biological agents.
-Elderly patients who are 90 years old or older.
-Pregnant women.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Ishii |
Organization
Nagoya University Graduate School of Medicine
Division name
Respiratory Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442167
mishii@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuichiro |
| Middle name | |
| Last name | Shindo |
Organization
Nagoya University Hospital
Division name
Respiratory Medicine
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
0527442167
Homepage URL
yshindo@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Yuichiro Shindo
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagoya University Hospital, Institutional Review Board
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
Tel
052-744-2423
iga-shinsa@adm.nagoya-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
名古屋大学医学部附属病院（愛知県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 03 | Month | 27 | 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
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2023 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 27 | 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
- This study is an observational study.
- Clinical information and blood samples will be collected at Nagoya University Hospital. Immunological analyses of blood samples will be performed at Nagoya University Graduate School of Medicine.
Management information
Registered date
| 2023 | Year | 03 | Month | 26 | Day |
Last modified on
| 2023 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057740
