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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034307
Receipt No. R000039112
Scientific Title Development of nonformalin fixed non-staining pathological tissue evaluation technique by Raman spectroscopy
Date of disclosure of the study information 2018/09/28
Last modified on 2019/06/24

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Basic information
Public title Development of nonformalin fixed non-staining pathological tissue evaluation technique by Raman spectroscopy
Acronym Unstained histopathology by Raman spectroscopy
Scientific Title Development of nonformalin fixed non-staining pathological tissue evaluation technique by Raman spectroscopy
Scientific Title:Acronym Unstained histopathology by Raman spectroscopy
Region
Japan

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

Objectives
Narrative objectives1 We will develop a morphological and qualitative evaluation technique of the biological tissue sample by spectroscopy in the unstained state.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between pathological tissue diagnosis 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) A patient with digestive disorder (esophageal tumor, stomach tumor, colon tumor or polyp) that undergoes endoscopic or surgical treatment.
(2) Lesions have been confirmed by endoscopic examination or other image examination.
(3) Clinical diagnosis is required by endoscopic diagnosis, contrast examination, CT, MRI, etc.
(4) To be able to decide participation by a willing age at age over 20 years old and under 80 years old.
(5) Those who have agreed in writing to participate in this clinical study.
Key exclusion criteria (1) Patient judged inappropriate at the discretion of the research doctor.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Ito
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code 135-8577
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 Hiroaki
Middle name
Last name Ito
Organization Showa University Koto Toyosu Hospital
Division name Digestive Disease Center
Zip code 135-8577
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 SHOWA UNIVERSITY KOTO TOYOSU HOSPITAL
Address 5-1-38 Toyosu, Koto-ku, Tokyo
Tel 0362036000
Email h.ito@med.showa-u.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 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 26 Day
Date of IRB
2018 Year 09 Month 28 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, resected specimens of patients who underwent endoscopic or surgical treatment were used as samples, and in each of the formalin unfixed unstained tissue, formalin fixed unstained tissue, unstained pathological tissue specimen, and stained pathological specimen Raman scattering light waveform is recorded and then it is compared prospectively with histopathologic diagnosis, clinical diagnosis, clinical information which becomes clear, investigating possibility of application to unstained tissue by Raman spectroscopy and biological evaluation .

Management information
Registered date
2018 Year 09 Month 28 Day
Last modified on
2019 Year 06 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039112

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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