UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031490 |
|---|---|
| Receipt number | R000035948 |
| Scientific Title | Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2021/03/27 13:58:05 |
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Basic information
Public title
Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Acronym
Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Scientific Title
Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Scientific Title:Acronym
Analysis the relationship of carbon monoxide in exhaled breath and non-small cell lung cancer
Region
| Japan |
Condition
Condition
Non-small cell lung cancer
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exhaled carbon monoxide concentration in non-smoking or former-smoking non-small cell lung cancer patients
Basic objectives2
Others
Basic objectives -Others
Exhaled carbon monoxide concentration
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Exhaled carbon monoxide concentration in non-smoking or former-smoking non-small cell lung cancer patients
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Measurement of expiratory carbon monoxide
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) Patients diagnosed pathologically as non-small cell lung carcinoma
2) Non smoking or former-smoking patients
3) Non-passive smoker
4) Patients without coexistence of other respiratory diseases
5) Patients without active infectious disease
6) Patients who can measure breath carbon monoxide concentration
7) After receiving sufficient explanation for the participation of this study, patients who obtained document consent by the patient's free will with sufficient understanding
Key exclusion criteria
1) Patients who are not diagnosed pathologically as non-small cell lung carcinoma
2) Current smoker
3) Passive smoker
4) Patients with complications of other malignant diseases
5) Patients with complications of other respiratory diseases
6) Patients with Active infectious disease
7) Patients who are deemed inappropriate as research subjects by research staff
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kiura |
| Middle name | |
| Last name | Katsuyuki |
Organization
Okayama University Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
700-8558
Address
2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture
TEL
086-235-7227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuya |
| Middle name | |
| Last name | Nishii |
Organization
Okayama University Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
700-8558
Address
2-5-1, Shikata cho, Kita Ku, Okayama city, Okayama prefecture
TEL
086-235-7227
Homepage URL
p98x94kg@s.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
Funding Source
Organization
Okayama University
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikatacho, Kitaku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-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
| 2018 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 02 | Month | 24 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 22 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 26 | Day |
Last modified on
| 2021 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035948
