UMIN-CTR Clinical Trial

Basic information
Public title	Multi-center observational study to investigate the effect of immune checkpoint inhibitors on MSI-H/dMMR solid tumors
Acronym	Multi-center observational study for MSI-H/dMMR solid tumors
Scientific Title	Multi-center observational study on clinicopathological/molecular features and therapeutic effects of immune checkpoint inhibitors in MSI-H/dMMR solid tumors
Scientific Title:Acronym	Multi-center observational study on the immune profiles of MSI-H/dMMR solid tumors
Region	Japan

Condition
Condition	MSI-H/dMMR solid tumor
Classification by specialty	Gastroenterology Hepato-biliary-pancreatic medicine Hepato-biliary-pancreatic surgery Vascular surgery Obsterics and gynecology
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	By evaluating the clinicopathological and molecular characteristics of solid tumors with MSI-H/dMMR, we aim to identify the mechanisms of resistance to immune checkpoint inhibitors, and to develop novel therapies.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of clinicopathological and molecular biological features related to the efficacy of immune checkpoint inhibitors.
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	1) Patients with unresectable or metastatic solid tumors with MSI-H or dMMR diagnosed by PCR/ NGS or IHC methods. 2) Patients with preserved tumor tissue specimens collected between July 2011 and December 2024. 3) Patients who have received or will receive immune checkpoint inhibitors. 4) Patients who have given written consent for this study
Key exclusion criteria	1) patients judged to be inappropriate by a physician in charge 2) Excluded from research subjects when there is a refusal to use samples and information (opt-out) in cases where consent has not been obtained.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Shohei Middle name Last name Koyama
Organization	Research Institute/Exploratory Oncology Research & Clinical Trial Center, National Cancer Center
Division name	Division of Cancer Immunology
Zip code	277-8577
Address	6-5-1,Kashiwanoha,Kashiwa-shi
TEL	04-7133-1111
Email	koyashou1023@gmail.com

Public contact
Name of contact person	1st name Kota Middle name Last name Itahashi
Organization	Research Institute/Exploratory Oncology Research & Clinical Trial Center, National Cancer Center
Division name	Division of Cancer Immunology
Zip code	277-8577
Address	6-5-1,Kashiwanoha,Kashiwa-shi
TEL	04-7133-1111
Homepage URL
Email	itahashi-tky@umin.org

Sponsor
Institute	National Cancer Center
Institute
Department

Funding Source
Organization	New Energy and Industrial Technology Development Organization
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Cancer center Hospital
Address	Tsukiji 5-1-1, Chuo-ku, Tokyo
Tel	03-3542-2511
Email	kitahash@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	2021 Year 07 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	Enrolling by invitation
Date of protocol fixation	2021 Year 04 Month 14 Day
Date of IRB	2021 Year 04 Month 14 Day
Anticipated trial start date	2021 Year 04 Month 14 Day
Last follow-up date	2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	not applicable

Management information
Registered date	2021 Year 07 Month 01 Day
Last modified on	2021 Year 07 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050988