UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042050 |
|---|---|
| Receipt number | R000047991 |
| Scientific Title | Clinical analysis for the efficacy of the treatment with hemoptysis and chronic hemosputum -A retrospective, single center, observational study- |
| Date of disclosure of the study information | 2020/10/08 |
| Last modified on | 2025/04/12 13:21:24 |
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Basic information
Public title
Clinical analysis for the efficacy of the treatment with hemoptysis and chronic hemosputum -A retrospective, single center, observational study-
Acronym
Study of therapeutic effectiveness in patients with hemoptysis and chronic hemosputum
Scientific Title
Clinical analysis for the efficacy of the treatment with hemoptysis and chronic hemosputum -A retrospective, single center, observational study-
Scientific Title:Acronym
Study of therapeutic effectiveness in patients with hemoptysis and chronic hemosputum
Region
| Japan |
Condition
Condition
hemoptysis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate long-term therapeutic effectiveness according to underlying diseases in patients with hemoptysis and chronic hemosputum
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of 1-year recurrence-free rate in patients with hemoptysis and chronic hemosputum due to tuberculosis, nontuberculous mycobacteriosis, pulmonary aspergillosis, bronchial ectasia, and cryptogenic hemoptysis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Hospitalized patients with hemoptysis and chronic hemosputum
2) Patients with hemoptysis and chronic hemosputum who received any treatment including medication, bronchoscopy, endovascular treatment, and surgical treatment.
Key exclusion criteria
1) Patients without any laboratory or imaging studies before treatment
2) Other ineligible status judged by pulmonary physicians
Target sample size
180
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Suzuki |
Organization
National Center for Global Health and Medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
03-3202-7181
msuzuki@hosp.ncgm.go.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Nagano |
Organization
National Center for Global Health and Medicine
Division name
Department of Respiratory Medicine
Zip code
162-8655
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
TEL
03-3202-7181
Homepage URL
nmatsubara-tky@umin.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine
in National Center for Global health and Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Global Health and Medicine
Address
1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan
Tel
03-3202-7181
msuzuki@hosp.ncgm.go.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 | 10 | Month | 08 | Day |
Related information
URL releasing protocol
https://pmc.ncbi.nlm.nih.gov/articles/PMC9773223/
Publication of results
Published
Result
URL related to results and publications
https://pmc.ncbi.nlm.nih.gov/articles/PMC9773223/
Number of participants that the trial has enrolled
180
Results
We identified 22 patients of cryptogenic hemoptysis. Angiography showed that the bronchial artery was responsible for hemoptysis in all patients, along with the intercostal artery in one patient (4.5%) and the inferior phrenic artery in one patient (4.5%). Immediate hemostasis was achieved in all patients. The recurrence-free rate was 100% for 1 month, 94.1% for 3 months, 94.1% for 12 months, and 87.4% for 24 months.
Results date posted
| 2025 | Year | 04 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We retrospectively reviewed the medical records of 120 consecutive patients who underwent BAE for hemoptysis between January 2010 and September 2018 at the National Center for Global Health and Medicine, Department of Respiratory Medicine, and identified patients with cryptogenic hemoptysis.
Participant flow
We retrospectively reviewed the medical records of 120 consecutive patients who underwent BAE for hemoptysis between January 2010 and September 2018 at the National Center for Global Health and Medicine, Department of Respiratory Medicine, and identified patients with cryptogenic hemoptysis.
Adverse events
none
Outcome measures
The clinical characteristics, angiographic findings, and short- and long-term outcomes of BAE were retrospectively analyzed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A retrospective analysis of the clinical data extracted from medical records.
Management information
Registered date
| 2020 | Year | 10 | Month | 08 | Day |
Last modified on
| 2025 | 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=R000047991
