UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044728 |
|---|---|
| Receipt number | R000050988 |
| Scientific Title | Multi-center observational study on clinicopathological/molecular features and therapeutic effects of immune checkpoint inhibitors in MSI-H/dMMR solid tumors |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2021/07/07 17:47:16 |
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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 | Obstetrics 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
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
itahashi-tky@umin.org
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050988
| Research Plan | |
|---|---|
| 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 |
