UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036361 |
|---|---|
| Receipt number | R000041426 |
| Scientific Title | The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02) |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2024/08/19 10:59:06 |
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Basic information
Public title
The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Acronym
The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Scientific Title
The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Scientific Title:Acronym
The concordance study of MSI status between MSI testing (FALCO) and modified Bethesda panel (GI-SCREEN-CRC-MSI additional study 02)
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the concordance of MSI status between testing using MSI panel (FALCO) and Bethesda panel.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Sensitivity and Specificity
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
1) Participate in GI-SCREEN MSI study
2) Patient who can provide written informed consent for secondary use of samples
3) Obtaining MSI status by MSI testing (FALCO)
4) Enough DNA samples
Key exclusion criteria
1)Patients who are unfit for the study as determined by the attending physician
Target sample size
435
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwano-ha, Kashiwa-shi, Chiba, Japan
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Hiroya |
| Middle name | |
| Last name | Taniguchi |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
277-8577
Address
6-5-1, Kashiwano-ha, Kashiwa-shi, Chiba, Japan
TEL
04-7133-1111
Homepage URL
hirtanig@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ono PHARMACEUTICAL CO.,LTD.
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
NCC IRB office
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2019 | Year | 04 | 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
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is clinical validation study of MSI (FALCO) in comparison with MSI testing using Bethesda panel for colorectal cancer patients.
Management information
Registered date
| 2019 | Year | 03 | Month | 31 | Day |
Last modified on
| 2024 | Year | 08 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041426
