UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009724 |
|---|---|
| Receipt number | R000011398 |
| Scientific Title | Analyzing images of Endobronchial Ultrasonography using guide sheath (EBUS-GS) to assist in the diagnosis of lung disease |
| Date of disclosure of the study information | 2013/01/08 |
| Last modified on | 2014/10/31 17:10:47 |
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Basic information
Public title
Analyzing images of Endobronchial Ultrasonography using guide sheath (EBUS-GS) to assist in the diagnosis of lung disease
Acronym
Analyzing images of Endobronchial Ultrasonography using guide sheath (EBUS-GS) to assist in the diagnosis of lung disease
Scientific Title
Analyzing images of Endobronchial Ultrasonography using guide sheath (EBUS-GS) to assist in the diagnosis of lung disease
Scientific Title:Acronym
Analyzing images of Endobronchial Ultrasonography using guide sheath (EBUS-GS) to assist in the diagnosis of lung disease
Region
| Japan |
Condition
Condition
lung disease(mainly contains lung cancer)
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether EBUS-GS images can contribute to the diagnosis of lung cancer or not.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic rate of lung cancer by analyzing images of EBUS-GS
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
Patient who has lung lesions on chest CT, and needs to perform a bronchoscopic examination using EBUS-GS.
Key exclusion criteria
1. When the informed consent can not be obtained by a patient.
2. When the lung lesion is too small to analyze.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | NORIAKI KURIMOTO |
Organization
St. Marianna University School of Medicine
Division name
Department of Thoracic Surgery
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki 216-8511
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | KEI MORIKAWA |
Organization
St. Marianna University School of Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki 216-8511
TEL
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 08 | 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
34 inflammatory cases and 105 lung cancers were analyzed. For lung cancers, 61 cases were adenocarcinoma consisting of 22 cases of EGFR mutation positive.
28 squamous cell carcinomas, 5 large cell carcinomas, and 8 small cell carcinomas.
For result of slope analysis, in inflammation diseases, infectious pneumonia and COP group showed higher values. However, mycobacterium revealed lower values. For lung cancers, adenocarcinoma displayed lower values while small cell carcinomas showed the highest values.
Using Kruskal Wallis test, there were significant differences seen between infectious pneumonia, COP and adenocarcinoma groups and between adenocarcinoma and small cell carcinoma groups.
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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 08 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2014 | Year | 08 | Month | 31 | Day |
Date trial data considered complete
| 2014 | Year | 08 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
RF spectral parameters provide a method to quantitatively differentiate, not just benign and malignant, but possibly the time process of inflammatory diseases and the pathological subtypes of lung cancer based on heterogeneity of the lesion.
Management information
Registered date
| 2013 | Year | 01 | Month | 08 | Day |
Last modified on
| 2014 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011398
