UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048399 |
|---|---|
| Receipt number | R000055128 |
| Scientific Title | Multicenter observational study on cellular and molecular biological analysis of normal and diffuse lung diseases |
| Date of disclosure of the study information | 2022/07/20 |
| Last modified on | 2022/07/18 18:48:18 |
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Basic information
Public title
Multicenter observational study on cellular and molecular biological analysis of normal and diffuse lung diseases
Acronym
Multicenter observational study on cellular and molecular biological analysis of normal and diffuse lung diseases
Scientific Title
Multicenter observational study on cellular and molecular biological analysis of normal and diffuse lung diseases
Scientific Title:Acronym
Multicenter observational study on cellular and molecular biological analysis of normal and diffuse lung diseases
Region
| Japan |
Condition
Condition
Patients to undergo or have undergone lung resection or lung transplantation for respiratory diseases at the department of thoracic surgery of the University of Tokyo Hospital.
Classification by specialty
| Pneumology | Chest surgery | Adult |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cellular and molecular biological analysis at the cellular level in normal human lungs and diffuse lung disease using lungs removed for testing or treatment of other diseases
Basic objectives2
Others
Basic objectives -Others
Finding a specific factor X that is linked to the disease state
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Risk ratios for the development of specific diseases in the population with specific factor X
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
To get free written consent based on the person's own free will or, if challenging, written consent by a surrogate, which can be obtained with complete understanding after receiving sufficient explanation for participation in this study
Key exclusion criteria
(1) Persons whom the principal (sub) investigator deems to be inappropriate to participate in this study
(2) If the lung specimen at the time of surgery is small and the collection of the specimen is considered to have a potential impact on the diagnosis.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hirokazu |
| Middle name | |
| Last name | Urushiyama |
Organization
The University of Tokyo Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
URUSHIYAMAH-INT@h.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Takumida |
Organization
The University of Tokyo Hospital
Division name
Department of Respiratory Medicine
Zip code
113-8655
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
TEL
03-3815-5411
Homepage URL
takumidah-int@h.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
Funding Source
Organization
Ministry of education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Faculty of Medicine of the University of Tokyo
Address
7-3-1, Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
| 2022 | Year | 07 | Month | 20 | 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
| 2022 | Year | 07 | Month | 13 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 13 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Consent will be obtained from the research subject and, if complex, from the surrogate, after which cell surface antigen analysis, gene/protein analysis, and histopathological evaluation will be performed using the remaining lung specimens or portions of paraffin blocks that are not needed for diagnosis. Some may not be analyzed immediately afterward and may be cryopreserved.
Management information
Registered date
| 2022 | Year | 07 | Month | 18 | Day |
Last modified on
| 2022 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055128
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
