UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018363 |
|---|---|
| Receipt number | R000021260 |
| Scientific Title | The basic study of cancer by using laser spectroscopy aimed at developing a non-invasive cancer diagnostic system |
| Date of disclosure of the study information | 2015/07/21 |
| Last modified on | 2015/07/22 15:50:30 |
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Basic information
Public title
The basic study of cancer by using laser spectroscopy aimed at developing a non-invasive cancer diagnostic system
Acronym
The basic study of cancer by using laser spectroscopy
Scientific Title
The basic study of cancer by using laser spectroscopy aimed at developing a non-invasive cancer diagnostic system
Scientific Title:Acronym
The basic study of cancer by using laser spectroscopy
Region
| Japan |
Condition
Condition
Upper gastrointestinal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Developing a non-invasive cancer diagnostic system
Basic objectives2
Others
Basic objectives -Others
We will search spectroscopic analytical methods possible to accurately distinguish between cancer cells and normal cells. Next, we will create a spectroscopic database for gastrointestinal malignant and normal tissues
by the best method aimed at developing a non-invasive cancer diagnostic system.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Being a spectroscopic analytical method possible to accurately distinguish between cancer cells and normal cells
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with esophageal or gastric cancer and scheduled for surgery
Key exclusion criteria
No exclusions
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuyuki Seto |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo , Japan
TEL
03-3815-5411
seto-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Satoshi Yoshijima |
Organization
Graduate School of Medicine, The University of Tokyo
Division name
Department of Gastrointestinal Surgery
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo , Japan
TEL
03-3815-5411
Homepage URL
yoshijima-kyt@umin.ac.jp
Sponsor or person
Institute
Department of Gastrointestinal Surgery,
Graduate School of Medicine, The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 07 | Month | 21 | 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
Enrolling by invitation
Date of protocol fixation
| 2012 | Year | 03 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 03 | Month | 07 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 06 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Only after patients undergoing surgery for upper gastrointestinal cancer agree to take part in this clinical study, we will use the surgically resected tissues for spectroscopic analysis. We will search spectroscopic analytical methods possible to accurately distinguish between cancer cells and normal cells. Next, we will create a spectroscopic database for gastrointestinal malignant and normal tissues
by the best method aimed at developing a non-invasive cancer diagnostic system.
Management information
Registered date
| 2015 | Year | 07 | Month | 21 | Day |
Last modified on
| 2015 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021260
