UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001955 |
|---|---|
| Receipt number | R000002384 |
| Scientific Title | Establishment of respiratory biomarker by metabolome |
| Date of disclosure of the study information | 2009/05/11 |
| Last modified on | 2024/11/21 09:49:38 |
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Basic information
Public title
Establishment of respiratory biomarker by metabolome
Acronym
Establishment of respiratory biomarker
Scientific Title
Establishment of respiratory biomarker by metabolome
Scientific Title:Acronym
Establishment of respiratory biomarker
Region
| Japan |
Condition
Condition
lung cancer, bronchial asthma, sleep apnea
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Detect and establish of new respiratory biomaker by metabolome analysis
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
discovery of new protein as respiratory biomaker
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
surgery
Interventions/Control_2
anti cancer drug
Interventions/Control_3
steroid therapy
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
| 15 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients with lung cancer will be treated with surgery or anti-cancer drug
The patients with asthma will be treated with steroid
Key exclusion criteria
the case that the patient does not agree with this study enroll
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Kobayashi |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
6580072
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe
TEL
078-382-5111
kkoba@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuyuki |
| Middle name | |
| Last name | Kobayas |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Respiratory Medicine, Department of Internal Medicine
Zip code
6500017
Address
7-5-2 Kusunoki-chou chuou-ku Kobe
TEL
078-382-5111
Homepage URL
kkoba@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
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University Graduate School of Medicine
Address
7-5-2 Kusunokicho Chuouku Kobe
Tel
078-382-5111
kkoba@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
| 2009 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/21411176/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/21411176/
Number of participants that the trial has enrolled
62
Results
A total of 58 metabolites (57 individual metabolites) were detected in serum, and 71 metabolites were detected in the lung tissue. The levels of 23 of the 58 serum metabolites were significantly changed in all lung cancer patients compared with healthy volunteers, and the levels of 48 of the 71 metabolites were significantly changed in the tumor tissue compared with the non-tumor tissue.
Results date posted
| 2024 | Year | 11 | Month | 21 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
29 healthy volunteers and 33 lung cancer patients
Participant flow
Serum samples from 29 healthy volunteers and 33 lung cancer patients with adenocarcinoma (n=12), squamous cell carcinoma (n=11), or small cell carcinoma (n=10) ranging from stage I to stage IV disease and lung tissue samples from 7 lung cancer patients including the tumor tissue and its surrounding normal tissue were used.
Adverse events
None
Outcome measures
A total of 58 metabolites (57 individual metabolites) were detected in serum, and 71 metabolites were detected in the lung tissue. The levels of 23 of the 58 serum metabolites were significantly changed in all lung cancer patients compared with healthy volunteers, and the levels of 48 of the 71 metabolites were significantly changed in the tumor tissue compared with the non-tumor tissue.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2009 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 05 | Month | 11 | Day |
Last modified on
| 2024 | Year | 11 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002384
