UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024144 |
|---|---|
| Receipt number | R000027798 |
| Scientific Title | Clinical evaluation study of newly developed microsatellite instability test kit |
| Date of disclosure of the study information | 2016/09/23 |
| Last modified on | 2017/10/05 11:24:36 |
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Basic information
Public title
Clinical evaluation study of newly developed microsatellite instability test kit
Acronym
GI-SCREEN-CRC-MSI substudy 01
Scientific Title
Clinical evaluation study of newly developed microsatellite instability test kit
Scientific Title:Acronym
GI-SCREEN-CRC-MSI substudy 01
Region
| Japan |
Condition
Condition
Advanced / recurrent colorectal cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the concordance between the standard method of MSI test using both tumor and normal samples and the newly developed MSI test kit using only tumor samples
Basic objectives2
Others
Basic objectives -Others
To compare the positive and negative concordance rate between standard genetic tastings and a newly developed MSI test kit
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate sensitivity (positive concordance rate) and specificity (negative concordance rate) between the standard method using both tumor and normal samples and the newly developed MSI test kit using only tumor samples
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 registered in GI-SCREEN CRC-MSI (UMIN000020437) and meet the following criteria;
1) Patients who agreed to the secondary usage of specimen when they agreed to GI-SCREEN CRC-MSI, and did not revoked their agreements.
2) Patients whose MSI status were decided by both tumor and normal samples in GI-SCREEN CRC-MSI
3) Sufficient quantity of DNA were extracted from patients' tumor sample for newly developed MSI test kit
Key exclusion criteria
1) Patients judged as inappropriate for this study by investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Yoshino |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
04-7133-1111
tyoshino@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideaki Bando |
Organization
National Cancer Center Hospital East
Division name
Department of Gastroenterology and Gastrointestinal Oncology
Zip code
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL
04-7133-1111
Homepage URL
hbando@east.ncc.go.jp
Sponsor or person
Institute
FALCO biosystems Ltd.
Institute
Department
Personal name
Funding Source
Organization
FALCO biosystems 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
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
| 2016 | Year | 09 | Month | 23 | 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
| 2016 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 11 | Month | 14 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 03 | Month | 10 | Day |
Other
Other related information
Five mononucleotides microsatellite marker, NR21, BAT26, BAT25, NR24 and MONO27, were utilized by newly developed MSI test kit.
Management information
Registered date
| 2016 | Year | 09 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027798
