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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000020437
Receipt No. 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

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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
Email 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
Email crc_msi_office@east.ncc.go.jp

Sponsor
Institute Saitama Cancer Center
National Cancer Center Hospital East
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023606

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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