UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033951 |
|---|---|
| Receipt number | R000038726 |
| Scientific Title | Clinical research for biomarkers in patients with drug-induced lung injury and their clinical significance |
| Date of disclosure of the study information | 2018/08/29 |
| Last modified on | 2023/09/06 21:35:31 |
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Basic information
Public title
Clinical research for biomarkers in patients with drug-induced lung injury and their clinical significance
Acronym
Clinical research for biomarkers in patients with drug-induced lung injury
Scientific Title
Clinical research for biomarkers in patients with drug-induced lung injury and their clinical significance
Scientific Title:Acronym
Clinical research for biomarkers in patients with drug-induced lung injury
Region
| Japan |
Condition
Condition
Cases of suspected drug-induced lung injury and performed bronchoalveolar lavage for diagnostic
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a new diagnostic method for drug-induced lung injury by immunity checkpoint inhibitor
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate of tumor infiltrating lymphocytes in bronchoalveolar lavage fluid in patients with drug-induced lung injury by immunity checkpoint inhibitors
Key secondary outcomes
Relationship with patient background and various examination items
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1: Patients who are suspected of drug-induced lung injury and undergo bronchoalveolar lavage for diagnostic purposes
2: Cases in which written consent was obtained to the principal (or substitute)
3: Age over 20 years old
4: Gender is unnecessary
5: Hospitalization / Outpatient is not required
Key exclusion criteria
Cases in which research researcher or shared medical doctor deemed inappropriate for participation in this study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Masahiro |
| Middle name | |
| Last name | Tahara |
Organization
University of Occupational and Environmental Health
Division name
Department of Respiratory Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka
TEL
093-691-7453
tahara-masahiro@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Tahara |
Organization
University of Occupational and Environmental Health
Division name
Department of Respiratory Medicine
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka
TEL
093-691-7453
Homepage URL
tahara-masahiro@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Department of Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Department of Respiratory Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
Iseigaoka, Yahatanishi-ku, Kitakyushu-city, Fukuoka, Japan
Tel
093-691-7453
daigakukanri@mbox.pub.uoeh-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
産業医科大学
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 29 | 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
| 2018 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 08 | Month | 29 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 29 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 29 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 29 | Day |
Other
Other related information
Evaluate at registration and one week after registration, one month, three months later. When registering, listen to the age, gender, date of onset, date of bronchoscopy enforcement, suspected drugs, smoking history, comorbidities, previous medical history, and life history. In addition, when the suspected drug is an antineoplastic agent, we will listen to the details of the carcinoma, the initial administration date of the antineoplastic agent, the administration course, and the radiation treatment history. At the time of each evaluation, we evaluate cough, dyspnea, sputum, and physical examination, height, weight, respiratory sound and ECOG-PS (indicator of whole body condition of patients with cancer). The test items include blood test (biochemistry, blood count, KL - 6, SP - D etc), arterial blood test, oxygen saturation, electrocardiogram, cardiac ultrasound examination, chest X - ray photograph, chest CT etc Appropriate at the time of evaluation. In addition, as data on bronchoscopy, we collect the execution site, collection rate, total cell number, cell fraction, etc.
Management information
Registered date
| 2018 | Year | 08 | Month | 29 | Day |
Last modified on
| 2023 | Year | 09 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038726
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
