UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054132 |
|---|---|
| Receipt number | R000058024 |
| Scientific Title | Clinico radiolo pathological assessment in familiar interstitial pneumonia |
| Date of disclosure of the study information | 2024/05/01 |
| Last modified on | 2024/04/12 13:26:54 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Multicenter retrospective study of clinico radiolo pathological assessment in familiar interstitial pneumonia
Acronym
Clinical study of familiar interstitial pneumonia
Scientific Title
Clinico radiolo pathological assessment in familiar interstitial pneumonia
Scientific Title:Acronym
Multidisciplinary discussion of familiar interstitial pneumonia
Region
| Japan |
Condition
Condition
familiar interstitial pneumonia
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify clinico radiolo pathological features of familiar interstitial pneumonia
Basic objectives2
Others
Basic objectives -Others
To assess the efficacy of antifibrotics between F-IPF and S-IPF
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
clinico radiolo pathological features of familiar interstitial pneumonia
Key secondary outcomes
Efficacy of antifibrotics
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
1) Familiar interstitial pneumonia was defined as patient-reported history of one or more additional family members affected with interstitial pneumonia
2) Type A: All patients with CT images and histological findings obtained by surgical lung biopsy, cryobiopsy, or autopsy
3) Type B: One patient with type A and the other patients with CT images but without histological findings
Key exclusion criteria
1) Patients without filling above mentioned criteria were excluded
2) Patients without providing opt-out consent were excluded
3) Patients considered inappropriate by primary doctor were excluded
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Keishi |
| Middle name | none |
| Last name | Sugino |
Organization
Jizankai Medical Fundation Tsuboi Hospital
Division name
Respiratory Medicine
Zip code
963-0197
Address
1-10-13, Nagakubo, Asakamachi, Koriyama City, Fukushima
TEL
024-946-0808
ks115108@tsuboi-hp.or.jp
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | None |
| Last name | Sugino |
Organization
Jizankai Medical Fundation Tsuboi Hospital
Division name
Respiratory Medicine
Zip code
963-0197
Address
1-10-13, Nagakubo, Asakamachi, Koriyama City, Fukushima
TEL
024-946-0808
Homepage URL
ks115108@tsuboi-hp.or.jp
Sponsor or person
Institute
Jizankai Medical Fundation Tsuboi Hospital
Institute
Department
Personal name
Funding Source
Organization
self-financing
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jizankai Medical Fundation Tsuboi Hospital
Address
1-10-13, Nagakubo, Asakamachi, Koriyama City, Fukushima
Tel
0249460808
ks115108@tsuboi-hp.or.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
| 2024 | Year | 05 | Month | 01 | 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
50
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
Completed
Date of protocol fixation
| 2023 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
MDD discussed as a retrospective multicentre study.
Management information
Registered date
| 2024 | Year | 04 | Month | 12 | Day |
Last modified on
| 2024 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058024
