UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024144
Receipt number R000027798
Scientific Title Clinical evaluation study of newly developed microsatellite instability test kit
Date of disclosure of the study information 2016/09/23
Last modified on 2017/10/05 11:24:36

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Basic information

Public title

Clinical evaluation study of newly developed microsatellite instability test kit

Acronym

GI-SCREEN-CRC-MSI substudy 01

Scientific Title

Clinical evaluation study of newly developed microsatellite instability test kit

Scientific Title:Acronym

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

1st name
Middle name
Last name Takayuki Yoshino

Organization

National Cancer Center Hospital East

Division name

Department of Gastroenterology and Gastrointestinal Oncology

Zip code


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

1st name
Middle name
Last name Hideaki Bando

Organization

National Cancer Center Hospital East

Division name

Department of Gastroenterology and Gastrointestinal Oncology

Zip code


Address

6-5-1, Kashiwanoha, Kashiwa, Chiba, 277-8577 Japan

TEL

04-7133-1111

Homepage URL


Email

hbando@east.ncc.go.jp


Sponsor or person

Institute

FALCO biosystems Ltd.

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Completed

Date of protocol fixation

2016 Year 05 Month 28 Day

Date of IRB


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


Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027798


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name