UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039559 |
|---|---|
| Receipt number | R000045113 |
| Scientific Title | Study on screening of malignant tumors by urine analysis |
| Date of disclosure of the study information | 2020/02/21 |
| Last modified on | 2023/08/25 17:52:36 |
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Basic information
Public title
Study on screening of malignant tumors by urine analysis
Acronym
Study on screening of malignant tumors by urine analysis
Scientific Title
Study on screening of malignant tumors by urine analysis
Scientific Title:Acronym
Study on screening of malignant tumors by urine analysis
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A simple screening method for cancer is established by analyzing and identifying autofluorescent components characteristic of cancer using urine that is easy to collect without pain.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The urine of cancer patients and noncancer urine are analyzed by liquid chromatography and compared to evaluate the effectiveness of cancer screening using urine fluorescent components.
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Lung cancer patients admitted to our department
Key exclusion criteria
Double cancer cases
Patients with a history of other cancers
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2276
kfunai@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhito |
| Middle name | |
| Last name | Funai |
Organization
Hamamatsu University School of Medicine
Division name
First Department of Surgery
Zip code
431-3192
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
TEL
053-435-2276
Homepage URL
kfunai@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu University School of 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
Hamamatsu University School of Medicine
Address
1-20-1 Handayama, Higashi-ku, Hamamatsu, Shizuoka
Tel
053-435-2680
crsupport@hama-med.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 | 02 | Month | 21 | Day |
Related information
URL releasing protocol
https://link.springer.com/article/10.1007/s11306-020-01721-y
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s11306-020-01721-y
Number of participants that the trial has enrolled
17
Results
A robust predictive biomarker for lung cancer was selected by the multivariate logistic analysis of fluorescent metabolites and identified to be O-aminohippuric acid (OAH). The area under the curve (AUC) data for OAH was 0.837.
Results date posted
| 2023 | Year | 08 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A total of 46 lung cancer patients and 185 volunteers without cancer were evaluated between November 2013 and November 2014.
Participant flow
A total of 46 lung cancer patients and 185 volunteers without cancer were evaluated between November 2013 and November 2014.
Adverse events
None
Outcome measures
A robust predictive biomarker for lung cancer was selected by the multivariate logistic analysis of fluorescent metabolites and identified to be O-aminohippuric acid (OAH).
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2013 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
we investigated metabolite fluorescence in human urine.
Management information
Registered date
| 2020 | Year | 02 | Month | 21 | Day |
Last modified on
| 2023 | Year | 08 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045113
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
