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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033951
Receipt No. 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 2019/02/28

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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
Middle name
Last name Masahiro Tahara
Organization University of Occupational and Environmental Health
Division name Department of Respiratory Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka
TEL 093-691-7453
Email tahara-masahiro@med.uoeh-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masahiro Tahara
Organization University of Occupational and Environmental Health
Division name Department of Respiratory Medicine
Zip code
Address 1-1 Iseigaoka, Yahatanishiku, Kitakyushu city, Fukuoka
TEL 093-691-7453
Homepage URL
Email tahara-masahiro@med.uoeh-u.ac.jp

Sponsor
Institute University of Occupational and Environmental Health, Department of Respiratory Medicine
Institute
Department

Funding Source
Organization University of Occupational and Environmental Health, Department of Respiratory 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
Address
Tel
Email

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 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
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
2019 Year 02 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038726

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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