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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000039559
Receipt No. 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 2020/02/21

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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
Email 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
Email kfunai@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 17
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 No longer recruiting
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
2020 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045113

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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