UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034307 |
|---|---|
| Receipt number | 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 19:01:15 |
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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
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
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
SHOWA UNIVERSITY KOTO TOYOSU HOSPITAL
Address
5-1-38 Toyosu, Koto-ku, Tokyo
Tel
0362036000
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039112
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
