UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040543 |
|---|---|
| Receipt number | R000045412 |
| Scientific Title | Characterization of gut microbiome in patients with lung adenocarcinoma |
| Date of disclosure of the study information | 2020/06/01 |
| Last modified on | 2020/05/27 14:39:31 |
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Basic information
Public title
Characterization of gut microbiome in patients with lung adenocarcinoma
Acronym
Characterization of gut microbiome in patients with lung adenocarcinoma
Scientific Title
Characterization of gut microbiome in patients with lung adenocarcinoma
Scientific Title:Acronym
Characterization of gut microbiome in patients with lung adenocarcinoma
Region
| Japan |
Condition
Condition
lung adenocarcinoma
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the relationship between gut microbiome and lung adenocarcinoma
Basic objectives2
Others
Basic objectives -Others
To assess the relationship between gut microbiome and lung adenocarcinoma
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
gut microbiome
Key secondary outcomes
none
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
patients with lung adenocarcinoma who agree to this study.
Key exclusion criteria
patients who do not agree to this study and those who are not appropriate for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe University School of medicine
Division name
Division of Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL
078-382-5660
tnagano@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Nagano |
Organization
Kobe University Hospital
Division name
Division of Respiratory Medicine
Zip code
650-0017
Address
7-5-2 Kusunoki-cho Chuo-ku Kobe City
TEL
078-382-5660
Homepage URL
tnagano@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory Medicine, Department of Internal Medicine, Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
National institutes of biomedical innovation, health and nutrition
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Hospital
Address
7-5-2 Kusunoki-cho Chuo-ku Kobe City
Tel
078-382-6669
chiken@med.kobe-u.ac.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 | 06 | 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
| 2020 | Year | 05 | Month | 26 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observational study
Management information
Registered date
| 2020 | Year | 05 | Month | 27 | Day |
Last modified on
| 2020 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045412
