UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043282
Receipt number R000049405
Scientific Title Evaluation of annotations for cancer gene panel testing using a genome-guided system
Date of disclosure of the study information 2021/02/08
Last modified on 2021/09/23 15:26:17

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Basic information

Public title

Evaluation of annotations for cancer gene panel testing using a genome-guided system

Acronym

Evaluation of annotations for cancer gene panel testing using a genome-guided system

Scientific Title

Evaluation of annotations for cancer gene panel testing using a genome-guided system

Scientific Title:Acronym

Evaluation of annotations for cancer gene panel testing using a genome-guided system

Region

Japan


Condition

Condition

Cancer patients who have undergone cancer gene panel testing at the St. Marianna University, School of Medicine Hospital Center for Genomic Medicine, and given consent to secondary use of the test results when they took the public insurance-covered cancer gene panel testing.

Classification by specialty

Not applicable

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

In this study, we will evaluate the results of annotation using the MH Guide from Molecular Health (Heidelberg, Germany) using genomic data generated from patients that underwent cancer gene panel testing at St. Marianna University Hospital.

Basic objectives2

Others

Basic objectives -Others

none

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Annotation success rate

Key secondary outcomes



Base

Study type

Others,meta-analysis etc


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

1. Patients who underwent cancer gene panel testing at the Center for Genomic Medicine, St. Marianna University School of Medicine Hospital
2. Patients who consented to the secondary use of panel test data conducted by the University in the consent form used for the insurance-covered cancer genetic panel tests

Key exclusion criteria

Cases in which the principal researcher determines that participation in this study is inappropriate

Target sample size

10


Research contact person

Name of lead principal investigator

1st name Yoshihisa
Middle name
Last name YAMANO

Organization

St. Marianna University School of Medicine Hospital

Division name

Center for Genomic Medicine

Zip code

216-8511

Address

2-16-1, Sugao, Miyamae-ku,Kawasaki

TEL

044-977-8111

Email

yyamano@marianna-u.ac.jp


Public contact

Name of contact person

1st name Yu
Middle name
Last name Sunakawa

Organization

St. Marianna University School of Medicine Hospital

Division name

Center for Genomic Medicine

Zip code

2168511

Address

2-16-1, Sugao, Miyamae-ku,Kawasaki

TEL

044-977-8111

Homepage URL


Email

y.sunakawa@marianna-u.ac.jp


Sponsor or person

Institute

St. Marianna University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Molecular Health Inc.

Organization

Division

Category of Funding Organization

Outside Japan

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

St. Marianna University School of Medicine IRB

Address

2-16-1, Sugao, Miyamae-kuKawasaki

Tel

0449778111

Email

k-sienbu.mail@marianna-u.ac.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

2021 Year 02 Month 08 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

Open public recruiting

Date of protocol fixation

2021 Year 02 Month 08 Day

Date of IRB

2021 Year 02 Month 08 Day

Anticipated trial start date

2021 Year 03 Month 01 Day

Last follow-up date

2021 Year 12 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2021 Year 02 Month 08 Day

Last modified on

2021 Year 09 Month 23 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049405


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name