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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028388
Receipt No. R000032497
Scientific Title Research on genomic test utilizing next generation sequencer for solid tumors and development of the genome database
Date of disclosure of the study information 2017/08/01
Last modified on 2019/08/06

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Basic information
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
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 Obsterics and gynecology Dermatology
Oto-rhino-laryngology Urology Oral surgery
Neurosurgery
Classification by malignancy Malignancy
Genomic information YES

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
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

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Niigata University
Institute
Department

Funding Source
Organization Denka Co., Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s) Niigata Prefecture
MEXT(Japan)

IRB Contact (For public release)
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
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
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)

Other administrative information
Date of disclosure of the study information
2017 Year 08 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 Enrolling by invitation
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
Other related information

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2019 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032497

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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