UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031130 |
|---|---|
| Receipt number | R000035559 |
| Scientific Title | Observational study on biomarker search of gastrointestinal tumors by flow cytometry |
| Date of disclosure of the study information | 2018/02/20 |
| Last modified on | 2018/02/04 00:27:45 |
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Basic information
Public title
Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Acronym
Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Scientific Title
Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Scientific Title:Acronym
Observational study on biomarker search of gastrointestinal tumors by flow cytometry
Region
| Japan |
Condition
Condition
Esophageal cancer, Gastric cancer, Colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Radiology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Quantitatively evaluate the cell cycle status of the tumor tissue cells using a rapid flow cytometric machine called Celltac PEAK and compare it with the clinicopathological factor, therapeutic effect, prognosis and establish a new biomarker As the aim of this research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
relapse free / progression-free survival period, pathology result, tumor marker etc., treatment effect (RECIST), numerical value measurable by image (tumor size, contrast effect, FDG-PET sugar metabolic rate, ADC value etc. ), Tumor genetic mutation (colon cancer)
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older who received a sufficient explanation about this research and received understanding and document consent by free will.
Key exclusion criteria
In the case of insufficient tissue volume for this examination during endoscopic examination or surgery.
When consent on this research can not be obtained.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hisahiro Matsubara |
Organization
Graduate school of medicine, Chiba University
Division name
Department of frontier surgery
Zip code
Address
1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL
043-226-2109
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Amagai |
Organization
Graduate school of medicine, Chiba University
Division name
Department of frontier surgery
Zip code
Address
1-8-1, Inohana, Chuo Ward, Chiba-shi, Chiba
TEL
043-226-2109
Homepage URL
afua2633@chiba-u.jp
Sponsor or person
Institute
Graduate school of medicine, Chiba University
Institute
Department
Personal name
Funding Source
Organization
NIHON KOHDEN CORPORATION
Organization
Division
Category of Funding Organization
Profit organization
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 | 02 | Month | 20 | 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
| 2017 | Year | 01 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | 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
Analyze the DNA histogram of tissues using Celltac PEAK and quantitatively evaluate the cell cycle state of tumor cells in the tissue.
Management information
Registered date
| 2018 | Year | 02 | Month | 04 | Day |
Last modified on
| 2018 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035559
