UMIN-CTR Clinical Trial

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 Obsterics 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
Email	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/
Email	Reiko.endo@parexel.com

Sponsor
Institute	MSD K.K.
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046067