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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034306
Receipt No. R000039109
Scientific Title Development of early cancer diagnosis technique using blood sample by Raman spectroscopy
Date of disclosure of the study information 2018/09/28
Last modified on 2018/09/28

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Basic information
Public title
Development of early cancer diagnosis technique using blood sample by Raman spectroscopy
Acronym Early cancer diagnosis by Raman spectroscopy
Scientific Title
Development of early cancer diagnosis technique using blood sample by Raman spectroscopy
Scientific Title:Acronym Early cancer diagnosis by Raman spectroscopy
Region
Japan

Condition
Condition Gastrointestinal disease
Classification by specialty
Gastroenterology Gastrointestinal surgery Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluate the utility of cancer diagnostic technology using blood as a sample by Raman spectroscopy, establish a technology for rapidly qualitative assessment of blood by Raman spectroscopy, and develop new cancer diagnostic technology.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between diagnosed disease type (malignant disease or not) and Raman scattering spectrum pattern.
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 (1) Persons who receive gastroscopy or colonoscopy.
(2) Persons who can decide to participate by age at age 20 or over, under 80 years old.
(3) Persons who have agreed in writing to participate in this clinical study.
Key exclusion criteria (1) A woman who may be pregnant, pregnant, or breastfeeding.
(2) Person who judged inappropriate by judgment of research doctor.
Target sample size 2000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL 03-6204-6000
Email h.ito@med.showa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Ito, MD, PhD
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code
Address 5-1-38 Toyosu, Koto-ku, Tokyo 135-8577 Japan
TEL 03-6204-6000
Homepage URL
Email h.ito@med.showa-u.ac.jp

Sponsor
Institute Showa University Koto Toyosu Hospital
Institute
Department

Funding Source
Organization Self funding
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
Address
Tel
Email

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 09 Month 28 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 14 Day
Date of IRB
Anticipated trial start date
2018 Year 09 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information For those who undergo upper endoscopic endoscopic examination or colonoscopy examination, using Raman spectroscopy to utilize opportunities for blood test before endoscopy, whether disease diagnosis by blood sample alone is possible positively evaluate.

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2018 Year 09 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039109

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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