UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059900 |
|---|---|
| Receipt number | R000068392 |
| Scientific Title | Microsatellite Instability (MSI) Screening Study for Resectable Solid Tumors (Excluding Colorectal Cancer) |
| Date of disclosure of the study information | 2025/11/27 |
| Last modified on | 2025/11/28 09:14:34 |
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Basic information
Public title
Microsatellite Instability (MSI) Screening Study for Resectable Solid Tumors (Excluding Colorectal Cancer)
Acronym
MSI Screening Study
Scientific Title
Microsatellite Instability (MSI) Screening Study for Resectable Solid Tumors (Excluding Colorectal Cancer)
Scientific Title:Acronym
MSI Screening Study
Region
| Japan |
Condition
Condition
Malignant solid tumors
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Pneumology |
| Nephrology | Obstetrics and Gynecology | Dermatology |
| Oto-rhino-laryngology | Orthopedics | Urology |
| Radiology | Oral surgery | Neurosurgery |
| Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To clarify the frequency of high-frequency microsatellite instability (MSI-H) in resectable solid tumors (excluding colorectal cancer) and the patient background according to MSI status.
Basic objectives2
Others
Basic objectives -Others
Clarifying the frequency of MSI in resectable solid tumors may accelerate the development of perioperative treatments using immune checkpoint inhibitors. Furthermore, the results of this study may serve as a reference for expanding the indications for MSI testing in resectable solid tumors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of MSI-H in Resectable Solid Cancers (Excluding Colorectal Cancer)
Key secondary outcomes
Association between MSI status and patient background factors
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Untreated malignant tumors confirmed by histopathological diagnosis
2)Age 18 years or older
3)Eastern Cooperative Oncology Group performance status (ECOG PS) 0 or 1
4)Not expected to achieve cure with local therapy using endoscopy, cystoscopy, etc.
5)A locally advanced solid cancer (excluding colorectal cancer) expected to achieve cure with surgical resection, radiation therapy, or chemoradiation therapy
6)Tumor tissue specimens can be submitted to this study
Key exclusion criteria
1)Presence of distant metastatic lesions
2)Clinical diagnosis of carcinoma in situ or mucosal carcinoma
3)Diagnosis of active concomitant cancer
*Lesions corresponding to carcinoma in situ or mucosal carcinoma deemed curable by local therapy are not included in active concomitant cancer
4)Severe concomitant diseases (e.g., poorly controlled diabetes, infections, symptomatic interstitial pneumonia, pulmonary fibrosis, etc.)
5)Lack of willingness to participate in the study
6)If the attending physician determines the patient is not suitable for enrollment in this study
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Bando |
Organization
National Cancer Center Hospital East
Division name
Department for the Promotion of Drug and Diagnostic Development
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
hbando@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Matsubara |
Organization
National Cancer Center Hospital East
Division name
Department of Gastrointestinal Medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba, Japan
TEL
04-7133-1111
Homepage URL
yumatsu4@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital East
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Falco Biosystems Co., Ltd.
Name of secondary funder(s)
Falco Biosystems Co., Ltd.
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
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
| 2025 | Year | 11 | Month | 27 | 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
| 2025 | Year | 05 | Month | 08 | Day |
Date of IRB
| 2025 | Year | 07 | Month | 10 | Day |
Anticipated trial start date
| 2025 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to clarify the frequency of high-frequency microsatellite instability (MSI-H) in resectable solid cancers (excluding colorectal cancer) and the patient background according to MSI status.
Management information
Registered date
| 2025 | Year | 11 | Month | 27 | Day |
Last modified on
| 2025 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068392
