UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031869 |
|---|---|
| Receipt number | R000036330 |
| Scientific Title | Evaluation of the ability of Raman spectroscopy to diagnose malignant lymphoma |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2021/04/06 13:30:50 |
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Basic information
Public title
Evaluation of the ability of Raman spectroscopy to diagnose malignant lymphoma
Acronym
Raman spectroscopy for diagnosis of malignant lymphoma
Scientific Title
Evaluation of the ability of Raman spectroscopy to diagnose malignant lymphoma
Scientific Title:Acronym
Raman spectroscopy for diagnosis of malignant lymphoma
Region
| Japan |
Condition
Condition
malignant lymphoma
Classification by specialty
| Ophthalmology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the possibility that Raman spectroscopy is useful for diagnosis of malignant lymphoma by using malignant lymphoma cell line and blood cells derived from healthy volunteer blood.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Human T cells, B cells, neutrophils and monocytes collected from healthy volunteers are cultured for several days to several weeks under maintenance condition or activation conditions imitating inflammatory environment. Raman spectroscopy are evaluated by Raman microscopy .
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
About 10 mL of blood is collected from healthy volunteers.
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
Healthy volunteers are recruited from the menber of the departments of Ophthalmology and Systems Neuroscience, Tokyo Medical and Dental University.
Key exclusion criteria
Those suffering from chronic diseases or some infectious diseases.
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Kyoko |
| Middle name | |
| Last name | Ohno-Matsui |
Organization
National University Corporation Tokyo Medical and Dental University
Division name
Department of Ophthalmology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
03-3813-6111
k.ohno.oph@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Iwasaki |
Organization
National University Corporation Tokyo Medical and Dental University
Division name
Department of Ophthalmology
Zip code
113-8510
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
TEL
03-3813-6111
Homepage URL
sahnya96@gmail.com
Sponsor or person
Institute
National University Corporation Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
The Ministry of Education,Culture,Sports,Science and Technology (MEXT)
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
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo 113 - 8510, JAPAN
Tel
03-3813-6111
info.bec@tmd.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 | 06 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.nature.com/articles/s41598-020-72762-5
Number of participants that the trial has enrolled
3
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
| 2018 | Year | 03 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 09 | Month | 24 | 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 | 03 | Month | 23 | Day |
Last modified on
| 2021 | Year | 04 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036330
| 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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