UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040387 |
|---|---|
| Receipt number | R000046067 |
| Scientific Title | Multi-centered, retrospective, observational study to evaluate the prevalence of MSI-H/dMMR in selected advanced solid tumors in Asia |
| Date of disclosure of the study information | 2020/05/15 |
| Last modified on | 2022/11/17 17:56:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Prevalence of Microsatellite Instability High (MSI-H) or DNA Mismatch Repair Deficiencies (dMMR) in Selected Advanced Solid Tumors in China, Japan, Korea, Singapore and Taiwan
Acronym
Prevalence of Microsatellite Instability High (MSI-H) or DNA Mismatch Repair Deficiencies (dMMR) in Selected Advanced Solid Tumors in Asia
Scientific Title
Multi-centered, retrospective, observational study to evaluate the prevalence of MSI-H/dMMR in selected advanced solid tumors in Asia
Scientific Title:Acronym
Multi-centered, retrospective, observational study to evaluate the prevalence of MSI-H/dMMR in selected advanced solid tumors in Asia
Region
| Japan | Asia(except Japan) |
Condition
Condition
Advanced solid tumor
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine | Gastrointestinal surgery |
| Hepato-biliary-pancreatic surgery | Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
MSI-H/dMMR prevalence in selected advanced solid tumor types in China, Japan, Korea, Singapore and Taiwan.
Basic objectives2
Others
Basic objectives -Others
Demographic and clinicopathological characteristics of MSI-H/dMMR patients, and treatment patterns for all patients in this study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MSI-H/dMMR prevalence in selected advanced solid tumor types
Key secondary outcomes
1. Demographic and clinicopathological characteristics of MSI-H/dMMR patients
2. Treatment patterns for all patients in this study
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
<Japanese cohort>
1. Patients must be over 20 years of age at diagnosis
2. Histologically or cytologically-documented, advanced solid tumor of one of the following types: endometrial, ovarian, cervical, biliary tract, pancreas and gastric cancer (including gastroesophageal junction).
3. Patients must have had a tumor tissue sample collected at the time of their advanced stage diagnosis for MSI-H testing that is no older than 3 years.
4. Patients must have MSI status tested by MSI Test Kit (FALCO).
5. Must have medical history documented within 3 months prior the pathology diagnosis.
6. Progressed or relapsed after standard of care treatment
7. Informed consent form (ICF) requirements or other requirements set forth by the local ethics committee have been met for patient.
Key exclusion criteria
N/A
Target sample size
1600
Research contact person
Name of lead principal investigator
| 1st name | Ryosuke |
| Middle name | |
| Last name | Watanabe |
Organization
MSD K.K.
Division name
Oncology Medical Affairs
Zip code
102-8667
Address
KITANOMARU SQUARE, 1-13-12 Kudan-kita, Chiyoda-ku, Tokyo
TEL
03-6272-0362
ldgproject@merck.com
Public contact
Name of contact person
| 1st name | Reiko |
| Middle name | |
| Last name | Endo |
Organization
Parexel International
Division name
GLOBAL MONITORING OPERATIONS
Zip code
104-0033
Address
1-21-2 Shinkawa, Chuou-ku, Tokyo
TEL
03-5543-9517
Homepage URL
https://japanhub.parexel.com/
Reiko.endo@parexel.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Cancer Institute Hospital Of JFCR
Address
3-8-31, Ariake, Koto-ku, Tokyo 135-8550, Japan
Tel
03-3520-0111
med.shinsa@jfcr.or.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
がん研究会有明病院（東京都）
国立がん研究センター中央病院（東京都）
神奈川県立がんセンター（神奈川県）
九州がんセンター（福岡県）
東邦大学大森病院（東京都）
広島市民病院（広島県）
大阪市立大学医学部附属病院（大阪府）
関西医科大学（大阪府）
奈良県立医科大学附属病院（奈良県）
京都大学医学部附属病院（京都府）
埼玉県立がんセンター（埼玉県）
愛媛大学医学部附属病院（愛媛県）
兵庫県立がんセンター（兵庫県）
東京慈恵会医科大学附属病院（東京都）
近畿大学病院（大阪府）
四国がんセンター（愛媛県）
福島県立医科大学附属病院（福島県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 05 | Month | 15 | 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
1075
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
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 23 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 02 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 17 | Day |
Date trial data considered complete
| 2022 | Year | 01 | Month | 17 | Day |
Date analysis concluded
| 2022 | Year | 02 | Month | 17 | Day |
Other
Other related information
This is a multi-center observational study and has two cohorts: 1) a Japan cohort and 2) a cohort from 4 other countries including China, Korea, Singapore and Taiwan.
In the China, Korea, Singapore and Taiwan cohort, data and tissues samples from advanced stage cancer patients will be collected retrospectively from centers within a 3year timeframe from study initiation. The dMMR test will use Ventana IHC panels.
In the Japan cohort, data will be collected retrospectively since the MSI Test Kit (FALCO) was approved as a CDx in Sep 2018. The MSI Test Kit (FALCO) test will use PCR.
Management information
Registered date
| 2020 | Year | 05 | Month | 13 | Day |
Last modified on
| 2022 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046067
