UMIN-CTR Clinical Trial

Public title

Research on genomic test utilizing next generation sequencer for solid tumors
and development of the genome database

Acronym

Genomic test for solid tumors and genome database

Scientific Title

Research on genomic test utilizing next generation sequencer for solid tumors
and development of the genome database

Scientific Title:Acronym

Genomic test for solid tumors and genome database

Region

Japan

Condition

Solid tumors
(Brain tumor, Thyroid cancer, Parathyroid cancer, Breast cancer, Lung adenocarcinoma,
Lung squamous cell carcinoma, Tongue cancer, Carcinoma of the oral cavity,
Pharyngeal cancer, Esophageal cancer, Gastric cancer, Carcinoma of the small intestine,
Colon cancer, Rectal cancer, Gastrointestinal stromal tumor, Hepatocellular carcinoma,
Intrahepatic bile duct cancer, Extrahepatic bile duct cancer, Gallbladder cancer,
Ampullary cancer, Pancreatic cancer, Duodenal cancer, Renal cell carcinoma,
Urothelial carcinoma, Bladder cancer, Prostate cancer, Carcinoma of the cervix uteri,
Carcinoma of the corpus uteri, Ovarian cancer, Skin cancer)

Classification by specialty

Gastroenterology	Hepato-biliary-pancreatic medicine	Pneumology
Endocrinology and Metabolism	Hematology and clinical oncology	Gastrointestinal surgery
Hepato-biliary-pancreatic surgery	Chest surgery	Endocrine surgery
Breast surgery	Obstetrics and Gynecology	Dermatology
Oto-rhino-laryngology	Urology	Oral surgery
Neurosurgery

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

The aim of this study is to develop a public genome database using the analytic results of
clinical sequencing for the solid tumors, and to develop the analytic technologies of
clinical sequencing for the solid tumors, and to reveal the association between genomic
alterations and the sensitivity of anti-cancer drugs by the integration of the genome
database with the economic, industrial and medical big data.

Basic objectives2

Others

Basic objectives -Others

Development of genome database

Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable

Primary outcomes

Development of genome database

Key secondary outcomes

Development of genome analytic technologies
Association between genomic alterations and the sensitivity of anti-cancer drugs
Development of artificial intelligence to predict genomic aberrations and the response of anti-cancer drugs in patients with solid tumors

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No. of arms

1

Purpose of intervention

Diagnosis

Type of intervention

Gene	Device,equipment

Interventions/Control_1

Genomic test
CANCERPLEX-JP
OncoGuide NCC oncopanel system
FndationONe CDx genome profile
GUARDANT360
MSI Analysis System
BRACAnalysis

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

1. Patients who underwent biopsy and/or surgical resection for the solid tumors (Brain tumor,
Thyroid cancer, Parathyroid cancer, Breast cancer, Lung adenocarcinoma, Lung squamous cell
carcinoma, Tongue cancer, Carcinoma of the oral cavity, Pharyngeal cancer,
Esophageal cancer, Gastric cancer, Carcinoma of the small intestine, Colon cancer,
Rectal cancer, Gastrointestinal stromal tumor,Hepatocellular carcinoma,
Intrahepatic bile duct cancer, Extrahepatic bile duct cancer, Gallbladder cancer,
Ampullary cancer, Pancreatic cancer, Duodenal cancer, Renal cell carcinoma,
Urothelial carcinoma, Bladder cancer, Prostate cancer, Carcinoma of the cervix uteri,
Carcinoma of the corpus uteri, Ovarian cancer, Skin cancer)
2. Primary tumor and/or treatment lesions are pathologically revealed as the above mentioned
solid tumors
3. History of the anti-cancer drug treatments is not considered
4. Patients with written informed consent

Key exclusion criteria

None

Target sample size

9000

Name of lead principal investigator

1st name	Toshifumi
Middle name
Last name	Wakai

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Digestive and General Surgery

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata

TEL

025-227-2228

Email

wakait@med.niigata-u.ac.jp

Name of contact person

1st name	Toshifumi
Middle name
Last name	Wakai

Organization

Niigata University Graduate School of Medical and Dental Sciences

Division name

Division of Digestive and General Surgery

Zip code

951-8510

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata

TEL

025-227-2228

Homepage URL

Email

wakait@med.niigata-u.ac.jp

Institute

Niigata University

Institute

Department

Personal name

Organization

Denka Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Niigata Prefecture
MEXT(Japan)

Organization

Ethics Committee on Genetic Analysis of Niigata University

Address

1-757 Asahimachi-dori, Chuo-ku, Niigata

Tel

025-227-2625

Email

ethics@adm.niigata-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

新潟大学大学院医歯学総合研究科（新潟県）
新潟県立がんセンター新潟病院（新潟県）
慶應義塾大学医学部 外科学 一般・消化器外科（東京都）
昭和大学横浜市北部病院消化器センター（神奈川県）
学校法人　昭和大学医学部乳腺外科（東京都）
聖路加国際病院　乳腺外科（東京都）
神奈川県立がんセンター消化器外科（神奈川県）
福島県立医科大学医学部器官制御外科学講座（福島県）
国立大学法人山梨大学消化器外科（山梨県）
国立大学法人浜松医科大学消化器・血管外科学分野（静岡県）
国立大学法人名古屋大学大学院腫瘍外科学分野（愛知県）
国立大学法人名古屋大学大学院消化器外科学分野（愛知県）
国立大学法人岐阜大学大学院腫瘍制御学講座 腫瘍外科学分野（岐阜県）
国立大学法人大阪大学大学院医学系研究科外科学講座呼吸器外科学（大阪府）
京都府立医科大学外科学教室消化器外科学部門（京都府）
国立大学法人九州大学大学院医学研究院　消化器・総合外科学分野（福岡県）
兵庫医科大学 乳腺・内分泌外科（兵庫県）
日本赤十字社長岡赤十字病院（新潟県）
日本赤十字社長岡赤十字病院消化器外科（新潟県）
新潟県厚生農業協同組合連合会長岡中央綜合病院（新潟県）
新潟県厚生農業協同組合連合会長岡中央綜合病院腫瘍内科（新潟県）
新潟県立中央病院病院（新潟県）
新潟県立中央病院外科（新潟県）
新潟県立新発田病院（新潟県）
新潟県立新発田病院（新潟県）
新潟市民病院病院（新潟県）
新潟市民病院消化器外科（新潟県）

Date of disclosure of the study information

2017

Year

08

Month

01

Day

URL releasing protocol

Publication of results

Partially published

URL related to results and publications

Number of participants that the trial has enrolled

995

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

Recruitment status

Completed

Date of protocol fixation

2017

Year

06

Month

21

Day

Date of IRB

2017

Year

06

Month

06

Day

Anticipated trial start date

2017

Year

06

Month

22

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

2022

Year

03

Month

31

Day

Other related information

Registered date

2017

Year

07

Month

26

Day

Last modified on

2022

Year

07

Month

29

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032497