UMIN-CTR Clinical Trial

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
Email	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
Email	sahnya96@gmail.com

Sponsor
Institute	National University Corporation Tokyo Medical and Dental University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036330