UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008328 |
|---|---|
| Receipt number | R000009737 |
| Scientific Title | Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry |
| Date of disclosure of the study information | 2012/07/03 |
| Last modified on | 2018/07/30 11:12:58 |
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Basic information
Public title
Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry
Acronym
Diagnosis of lung cancer using IMS
Scientific Title
Detection of histological type and genetic mutation in lung cancer using ion mobility spectrometry
Scientific Title:Acronym
Diagnosis of lung cancer using IMS
Region
| Japan |
Condition
Condition
To investigate if IMS can diagnosis histological type and genetic mutation using volatile organic compounds (VOCs) in patients with lung cancer.
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To identify specific VOC patterns in patients with lung cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To investigate if IMS can diagnosis histological type and genetic mutation using volatile organic compounds (VOCs) in patients with lung cancer.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Lung cancer:
To collect 10ml of exhaled air using BioScout.
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) No treatment of lung cancer
2) To agree to give informed consent
Key exclusion criteria
1) To refuse to give informed consent
2) Lung cancer of unknown histological type
3) Patients with no diagnosis of lung cancer
4) Patients who are pregnant, possibly pregnant, or lactating.
5) Patients with renal failure. (serum creatinine > 2.0 mg/dL, BUN > 30mg/dl)
6) AST or ALT > 100IU
7) Patients with severe diabetes, hyperlipidemia or hyperuricemia
8) Patients who are judged inappropriate by the doctor in charge.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Teruomi Miyazawa |
Organization
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Division name
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Zip code
Address
2-16-1 Sugao Miyamae-ku, Kawasaki, Kanagawa, Japan 216-8511
TEL
044-977-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Handa |
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, Kanagawa, Japan 216-8511
TEL
044-977-8111
Homepage URL
Sponsor or person
Institute
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Division of Respiratory and Infectious Diseases, Department of Internal Medicine
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
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
| 2012 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2012 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
| 2014 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2014 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 07 | Month | 03 | Day |
Last modified on
| 2018 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
