UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039945 |
|---|---|
| Receipt number | R000045539 |
| Scientific Title | An observational study for clinical utility and safety of bronchoalveolar lavage for interstitial lung disease that occurred during treatment for lung cancer. |
| Date of disclosure of the study information | 2020/03/27 |
| Last modified on | 2023/03/28 13:18:08 |
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Basic information
Public title
An observational study for clinical utility and safety of bronchoalveolar lavage for interstitial lung disease that occurred during treatment for lung cancer.
Acronym
An observational study for clinical utility and safety of bronchoalveolar lavage for interstitial lung disease that occurred during treatment for lung cancer.
Scientific Title
An observational study for clinical utility and safety of bronchoalveolar lavage for interstitial lung disease that occurred during treatment for lung cancer.
Scientific Title:Acronym
An observational study for clinical utility and safety of bronchoalveolar lavage for interstitial lung disease that occurred during treatment for lung cancer.
Region
| Japan |
Condition
Condition
interstitial lung disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study purpose is assess clinical utility and safety of bronchoalveolar lavage for interstitial lung disease that occurred during treatment for lung cancer.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of cell count, cell fraction, subset of lymphocyto on BAL in patients with drug induced pneumonitis or radiation pneumonitis
Key secondary outcomes
Complication of BAL
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. Patient with lung cancer
2. patient who have developed with interstitial lung disease and who is going to receive BAL
3. Age at the time of consent acquisition is 20 years or older
4. Written informed consent for participation in this study has been obtained
Key exclusion criteria
1. Patient difficult to receive bronchoscopy due to severe respiratory failure or unstable hemodynamics
2. Patient with high bleeding tendency
3. Pregnant
4. Other cases judged by the attending physician to be inappropriate as subjects
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka municipal hospital
Division name
Department of respiratory medicine
Zip code
515-8544
Address
1550, Tonomachi, Matsusaka, Mie
TEL
0598-23-1515
mchsakaguchi@city-hosp.matsusaka.mie.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Sakaguchi |
Organization
Matsusaka municipal hospital
Division name
Department of respiratory medicine
Zip code
515-8544
Address
1550, Tonomachi, Matsusaka, Mie
TEL
0598-23-1515
Homepage URL
mchsakaguchi@city-hosp.matsusaka.mie.jp
Sponsor or person
Institute
Matsusaka municipal hospital
Institute
Department
Personal name
Funding Source
Organization
Matsusaka municipal hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Matsusaka municipal hospital
Address
1550, Tonomachi
Tel
0598-23-1515
mch1031@city-hosp.matsusaka.mie.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
| 2020 | Year | 03 | Month | 27 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Now, this clinical trial is ongoing.
Management information
Registered date
| 2020 | Year | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045539
