UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033490 |
|---|---|
| Receipt number | R000038178 |
| Scientific Title | Development of novel biomarker for diagnosis of gastrointestinal cancer using liquid biopsy |
| Date of disclosure of the study information | 2018/09/01 |
| Last modified on | 2018/09/04 11:13:32 |
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Basic information
Public title
Development of novel biomarker for diagnosis of gastrointestinal cancer using liquid biopsy
Acronym
Development of novel biomarker for diagnosis of gastrointestinal cancer using liquid biopsy
Scientific Title
Development of novel biomarker for diagnosis of gastrointestinal cancer using liquid biopsy
Scientific Title:Acronym
Development of novel biomarker for diagnosis of gastrointestinal cancer using liquid biopsy
Region
| Japan |
Condition
Condition
gastrointestinal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify whether a diagnosis of gastrointestinal cancer or prediction of treatment effect is possible, changes in nucleic acid and miRNA expression before and after treatment are examined using liquid biopsy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficacy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with gastrointestinal cancer (gastric cancer, colorectal cancer, esophageal cancer, gastrointestinal neuroendocrine tumor, pancreatic cancer, liver cancer), from which written informed consent was obtained.
Key exclusion criteria
Patients in which consent was not obtained.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Community Medicine for Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
088-633-7122
yasushis2012@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasushi Sato |
Organization
Tokushima University Graduate School of Biomedical Sciences
Division name
Department of Community Medicine for Gastroenterology and Oncology
Zip code
Address
3-18-15, Kuramoto-cho, Tokushima city
TEL
088-633-7122
Homepage URL
yasushis2012@gmail.com
Sponsor or person
Institute
Tokushima University
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
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 | 01 | 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
Preinitiation
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 09 | 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
nothing particular
Management information
Registered date
| 2018 | Year | 07 | Month | 24 | Day |
Last modified on
| 2018 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038178
