UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000031407
Receipt number R000035861
Scientific Title Multicenter retrospective observational study of data of cancer clinical sequence assay, MSK-IMPACT
Date of disclosure of the study information 2018/03/01
Last modified on 2022/02/23 14:51:44

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Basic information

Public title

Multicenter retrospective observational study of data of cancer clinical sequence assay, MSK-IMPACT

Acronym

Multicenter retrospective observational study of data of MSK-IMPACT

Scientific Title

Multicenter retrospective observational study of data of cancer clinical sequence assay, MSK-IMPACT

Scientific Title:Acronym

Multicenter retrospective observational study of data of MSK-IMPACT

Region

Japan


Condition

Condition

Solid malignant tumor

Classification by specialty

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

To summarize the earliest cases of MSK-IMPACT examination introduced for the first time in Japan and to report it as data of cancer of the Japanese.

Basic objectives2

Others

Basic objectives -Others

Evaluate the detection rate of a druggable gene

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection rate of druggable gene

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

Patient who conducted MSK-IMPACT test at Yokohama City University or Juntendo University.

Key exclusion criteria

When patient consent is not obtained

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shingo Kato

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

3-9 Fukuura, Kanazawa-Ku, Yokohama

TEL

+81-45-787-2800

Email

shin800m@yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Shingo Kato

Organization

Yokohama City University School of Medicine

Division name

Department of Gastroenterology and Hepatology

Zip code


Address

3-9 Fukuura, Kanazawa-Ku, Yokohama

TEL

+81-45-787-2800

Homepage URL


Email

shin800m@yokohama-cu.ac.jp


Sponsor or person

Institute

Yokohama City University

Institute

Department

Personal name



Funding Source

Organization

Own expense

Organization

Division

Category of Funding Organization

Self funding

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

2018 Year 03 Month 01 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

2017 Year 09 Month 28 Day

Date of IRB

2017 Year 11 Month 27 Day

Anticipated trial start date

2018 Year 03 Month 01 Day

Last follow-up date

2018 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

Analyze the results of cancer clinical sequence


Management information

Registered date

2018 Year 02 Month 21 Day

Last modified on

2022 Year 02 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035861


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name