UMIN-CTR Clinical Trial

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 Development of artificial intelligence to predict genomic aberrations and the response of anti-cancer drugs in patients with solid tumors

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	Partially published

Result
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

Progress
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
Other related information

Management information
Registered date	2017 Year 07 Month 26 Day
Last modified on	2022 Year 07 Month 29 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032497