UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Clinical evaluation study of newly developed microsatellite instability test kit
Title of the study (Brief title)	GI-SCREEN-CRC-MSI substudy 01
Region	Japan

Condition
Condition	Advanced / recurrent colorectal cancer
Classification by specialty	Gastroenterology Gastrointestinal surgery Laboratory medicine
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	To evaluate the concordance between the standard method of MSI test using both tumor and normal samples and the newly developed MSI test kit using only tumor samples
Basic objectives2	Others
Basic objectives -Others	To compare the positive and negative concordance rate between standard genetic tastings and a newly developed MSI test kit
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate sensitivity (positive concordance rate) and specificity (negative concordance rate) between the standard method using both tumor and normal samples and the newly developed MSI test kit using only tumor samples
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	Patients registered in GI-SCREEN CRC-MSI (UMIN000020437) and meet the following criteria; 1) Patients who agreed to the secondary usage of specimen when they agreed to GI-SCREEN CRC-MSI, and did not revoked their agreements. 2) Patients whose MSI status were decided by both tumor and normal samples in GI-SCREEN CRC-MSI 3) Sufficient quantity of DNA were extracted from patients' tumor sample for newly developed MSI test kit
Key exclusion criteria	1) Patients judged as inappropriate for this study by investigator
Target sample size	300

Research contact person
Name of lead principal investigator	Takayuki Yoshino
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Gastrointestinal Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	04-7133-1111
Email	tyoshino@east.ncc.go.jp

Public contact
Name of contact person	Hideaki Bando
Organization	National Cancer Center Hospital East
Division name	Department of Gastroenterology and Gastrointestinal Oncology
Address	6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan
TEL	04-7133-1111
Homepage URL
Email	hbando@east.ncc.go.jp

Sponsor
Institute	FALCO biosystems Ltd.
Institute
Department

Funding Source
Organization	FALCO biosystems Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2016 Year 09 Month 23 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 05 Month 28 Day
Anticipated trial start date	2016 Year 11 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2017 Year 03 Month 10 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Five mononucleotides microsatellite marker, NR21, BAT26, BAT25, NR24 and MONO27, were utilized by newly developed MSI test kit.

Management information
Registered date	2016 Year 09 Month 23 Day
Last modified on	2017 Year 10 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027798