UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034306
Receipt number 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 10:25:54

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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 or person

Institute

Showa University Koto Toyosu Hospital

Institute

Department

Personal name



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

Value
https://center6.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