UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020437 |
|---|---|
| Receipt number | R000023606 |
| Scientific Title | The multicenter study to examine microsatellite instability (MSI) in advanced gastrointestinal and abdominal malignant tumor |
| Date of disclosure of the study information | 2016/01/05 |
| Last modified on | 2019/08/28 09:41:09 |
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Basic information
Public title
The multicenter study to examine microsatellite instability (MSI) in advanced gastrointestinal and abdominal malignant tumor
Acronym
The multicenter study to examine MSI in advanced gastrointestinal and abdominal malignant tumor (GI-SCREEN MSI)
Scientific Title
The multicenter study to examine microsatellite instability (MSI) in advanced gastrointestinal and abdominal malignant tumor
Scientific Title:Acronym
The multicenter study to examine MSI in advanced gastrointestinal and abdominal malignant tumor (GI-SCREEN MSI)
Region
| Japan |
Condition
Condition
gastrointestinal and abdominal malignant tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The frequency of MSI-H in advanced gastrointestinal and abdominal malignant tumor
Basic objectives2
Others
Basic objectives -Others
Association between MSI and MMR-IHC status and cancer genome alterations, molecular biological characteristics, clinicopathological features or prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The frequency of MSI-H in advanced gastrointestinal and abdominal malignant tumor
Key secondary outcomes
Association between MSI and MMR-IHC status and cancer genome alterations, molecular biological characteristics, clinicopathological features or prognosis
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
1) Patients with histologically confirmed or clinically suspected advanced gastrointestinal or abdominal malignant tumor
a: Colorectal cancer
b: Gastric cancer
c: Esophageal cancer
d: Hepatocellular carcinoma
e: Biliary tract cancer
f: Pancreatic cancer
g: Small intestine, Appendix or Anal canal cancer
h: Neuroendocrine tumor or cancer of GI
i: Gastrointestinal stromal tumor
2) Planned to receive systemic chemotherapy for malignant tumor
3) Presence or ability to acquire sufficient samples for MSI and/or MMR-IHC testing
4) Written informed consent was obtained
Key exclusion criteria
1) Judged by the investigator to be inappropriate for study participation for any reason
Target sample size
3500
Research contact person
Name of lead principal investigator
| 1st name | Kiwamu |
| Middle name | |
| Last name | Akagi |
Organization
Saitama Cancer Center
Division name
Division of Molecular Diagnosis and Cancer Prevention
Zip code
362-0806
Address
780, Komuro, Ina-machi, Kitaadachi-gun, Saitama, 362-0806, Japan
TEL
048-722-1111
akagi@cancer-c.pref.saitama.jp
Public contact
Name of contact person
| 1st name | Wataru |
| Middle name | |
| Last name | Okamoto |
Organization
National Cancer Center Hospital East
Division name
Clinical Research Support Office
Zip code
277-8577
Address
6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
crc_msi_office@east.ncc.go.jp
Sponsor or person
Institute
Saitama Cancer Center
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
MSD KK
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
MSD KK
FALCO biosystems Ltd.
Name of secondary funder(s)
FALCO biosystems Ltd.
National Cancer Center Research and Development Fund
AMED
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
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
| 2016 | Year | 01 | Month | 05 | 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
2678
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
No longer recruiting
Date of protocol fixation
| 2015 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: cross-sectional study
Target population:the patients who visit the research implementation facility until March 31 2019 from research permit date and meet the selection criteria
Measurement items: one base repeat marker (BAT-25, BAT-26, MONO-27, NR-21, NR-24), MMR protein expression
If the patient is participating in SCRUM-Japan GI-SCREEN studies (GI-SCREEN 2013-01-CRC (UMIN000016343), GI-SCREEN 2015-01-non CRC (UMIN000016344), GOZILA study (UMIN000029315), Immune-related gene signiture profiling study (UMIN000029565), etc.), we investigate the association between MSI and MMR protein expression status and cancer genome alterations, molecular biological characteristics, clinicopathological features or prognosis using the data of this study and SCRUM-Japan GI-SCREEN studies.
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2019 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023606
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
