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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040387
Receipt No. 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 2020/05/12

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Basic information
Public title Prevalence of Microsatellite Instability High (MSI-H) or DNA Mismatch Repair Deficiencies (dMMR) in Selected Advanced Solid Tumors in Australia, 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) Australia

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 Australia, 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

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
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 Preinitiation
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
2021 Year 04 Month 15 Day
Date trial data considered complete
2021 Year 04 Month 15 Day
Date analysis concluded
2021 Year 05 Month 16 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 5 other countries including Australia, China, Korea, Singapore and Taiwan.

In the Australia, 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
2020 Year 05 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046067

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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