UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017045 |
|---|---|
| Receipt number | R000019772 |
| Scientific Title | Development of histopathological methodology without staining using a spectroscopy |
| Date of disclosure of the study information | 2015/04/04 |
| Last modified on | 2024/04/10 09:30:37 |
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Basic information
Public title
Development of histopathological methodology without staining using a spectroscopy
Acronym
NOn-staining histopathological methodology using a spectroscopy
Scientific Title
Development of histopathological methodology without staining using a spectroscopy
Scientific Title:Acronym
NOn-staining histopathological methodology using a spectroscopy
Region
| Japan |
Condition
Condition
Esophageal, gastric, colorectal, hepatic, pancreatic, bile duct, and gallbladder cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Hematology and clinical oncology |
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
1. Development of histopathological diagnostic method without staining for gastrointestinal, hepatic, pancreatic, and gallbladder cancer.
2. Development of method detecting circulating tumor cells without labeling.
3. Development of method detecting substances related diseases without labeling.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accuracy of diagnosis of cancer cells by spectroscopy.
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) patients with histologically proven cancer. And benign disease patients without cancer.
(2) age 20-80 years.
(3) Eastern Cooperative Oncology Group. performance status 0 or 1.
(4) sufficient organ function.
(5) written informed consent.
Key exclusion criteria
(1) synchronous or metachronous malignancy.
(2) pregnant or breastfeeding women.
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ito |
Organization
Showa University
Division name
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8145
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
Advanced Cancer Translational Research Institute
Zip code
142-8555
Address
1-5-8 Hatanodai Shinagawa-ku Tokyo
TEL
03-3784-8145
Homepage URL
h.ito@med.showa-u.ac.jp
Sponsor or person
Institute
Advanced Cancer Translational Research Institute, Showa University
Institute
Department
Personal name
Funding Source
Organization
Advanced Cancer Translational Research Institute, Showa University
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
03-6204-6000
kototoyosu@ofc.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
| 2015 | Year | 04 | Month | 04 | 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
Suspended
Date of protocol fixation
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Comparison of diagnosis between spectroscopy and normal histopathological examination.
Management information
Registered date
| 2015 | Year | 04 | Month | 04 | Day |
Last modified on
| 2024 | Year | 04 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019772
