UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032926 |
|---|---|
| Receipt number | R000037537 |
| Scientific Title | Analysis for autoimmune components and the disease activity of interstitial pneumonia patients |
| Date of disclosure of the study information | 2018/06/08 |
| Last modified on | 2026/06/22 11:42:15 |
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Basic information
Public title
Analysis for autoimmune components and the disease activity of interstitial pneumonia patients
Acronym
Interstitial pneumonia associated with autoimmune
Scientific Title
Analysis for autoimmune components and the disease activity of interstitial pneumonia patients
Scientific Title:Acronym
Interstitial pneumonia associated with autoimmune
Region
| Japan |
Condition
Condition
patients with interstitial pneumonia
Classification by specialty
| Medicine in general | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
positive ratio of autoantibodies
Basic objectives2
Others
Basic objectives -Others
Positive ratio of autoantibodies and the survival rate of the patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
positive ratio of autoantibodies
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 with interstititial shadow
COPD
Asthma
Key exclusion criteria
<20 years old
Target sample size
900
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Yoshiki |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
TEL
0282861111
ishiiysk@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Yasuo |
| Middle name | |
| Last name | Shimizu |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
321-0293
Address
880 Kitakobayashi, Mibu, Tochigi 321-0293, Japan
TEL
0282861111
Homepage URL
yasuo-s@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Dokkyo University Hospital
Address
880 Kitakobayashi, Mibu, Shimotsugagun, Tochigi
Tel
0282-87-2151
r-kenkyu@dokkyomed.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
| 2018 | Year | 06 | Month | 08 | Day |
Related information
URL releasing protocol
none
Publication of results
Published
Result
URL related to results and publications
https://www.jstage.jst.go.jp/article/jcbn/67/2/67_20-5/_article
Number of participants that the trial has enrolled
285
Results
Ro52 mono-positive patients showed worse at 2-years survival than those who were Ro52 negative (p = 0.022, HR = 5.88, 95% CI 1.29-26.75). Ro52 positive patients accounted for more than half of the MPT positive patients without connective tissue diseases. Detection of Ro52 auto-antibodies may be useful for assessing the risk of progression in idiopathic interstitial pneumonia patients without connective tissue diseases and a low anti-nucleolar antibody titer.
Results date posted
| 2026 | Year | 06 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with autoimmune background
Participant flow
Patients who visited the hospital
Adverse events
none
Outcome measures
Among interstitial pneumonia patients without connective tissue diseases, the Ro52 mono-positive patients showed worse at 2-years survival than those who were Ro52 negative (p = 0.022, HR = 5.88, 95% CI 1.29-26.75).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 04 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 14 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 06 | Month | 08 | Day |
Last modified on
| 2026 | Year | 06 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000037537
