UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022762 |
|---|---|
| Receipt number | R000026222 |
| Scientific Title | Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer |
| Date of disclosure of the study information | 2016/07/01 |
| Last modified on | 2017/08/13 19:35:07 |
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Basic information
Public title
Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer
Acronym
Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer
Scientific Title
Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer
Scientific Title:Acronym
Risk factors of respiratory infectious complications after diagnostic bronchoscopy for the diagnosis of lung cancer
Region
| Japan |
Condition
Condition
Lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to clarify the risk factors associated with respiratory infectious complications after diagnostic bronchoscopy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
to elucidate the risf factors of respiratory infectious complications
Key secondary outcomes
frequency of respiratory infectious complications
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
patients who will receive the bronchoscopy for the diagnosis of lung cancer
Key exclusion criteria
patients who do not accept to be included in the observational study
patients for whom primary physicians do not think suitable for the clinical study
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shiro Imokawa |
Organization
Iwata City Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
512-3 Okubo, Iwata, Shizuoka, 438-8550, Japan
TEL
0538-38-5000
fmrcw925@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shiro Imokawa |
Organization
Iwata City Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
512-3, Ookubo, Iwata, Shizuoka, 438-8550, Japan
TEL
0538-38-5000
Homepage URL
fmrcw925@ybb.ne.jp
Sponsor or person
Institute
Iwata City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
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
磐田市立総合病院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | 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
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
| 2016 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
frequency of respiratory infectious complications within 14 days after diagnostic bronchoscopy for the diagnosis of lung cancer and check the following:height, weight, BMI, TP, Alb, TG, TC, BS, HbA1c, liver function, renal function, arterial blood gas analysis, associateddiseases, the size, characteristic findings and location of the tumor,
Management information
Registered date
| 2016 | Year | 06 | Month | 15 | Day |
Last modified on
| 2017 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026222
