UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Integrated database construction of genomic information and clinical information obtained by clinical sequence
Title of the study (Brief title)	Integrated database construction of genomic information and clinical information obtained by clinical sequence
Region	Japan

Condition
Condition	Malignant tumor
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 Orthopedics Urology Oral surgery Neurosurgery
Classification by malignancy	Malignancy
Genomic information	YES

Objectives
Narrative objectives1	We will establish a consolidated database between gene mutation results and clinical information of cancer patients who underwent clinical sequencing, and will promote domestic completion type cancer genome medicine and aim for improvement of cancer treatment outcomes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1) Percentage of cases in which clinical sequences were received, with actionable mutation (unapproved for genetic mutation and with matching drugs including investigational drugs) 2) Percentage of patients who selected treatment based on clinical sequence results 3) Treatment outcome of case 2) 4) Frequency of accidental findings and secondary findings 5) In addition, the sequence success rate, the frequency of genetic mutation for all cases, the frequency of genetic mutation in carcinomas, the relationship between sequence results and survival time, etc. are extensively studied.
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	20 years-old <=
Age-upper limit	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Malignant diseases for which established clinical diagnosis is confirmed 2) Case in which the written agreement was acquired with the free will of the patient after understanding after receiving sufficient explanation for participation in the research
Key exclusion criteria	Cases judged inappropriate by the attending physician.
Target sample size	100

Research contact person
Name of lead principal investigator	Hisahiro Matsubara
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Frontier Surgery
Address	1-8-1 Inohana,Chuo-Ku,Chiba,Chiba,JAPAN
TEL	043-226-2109
Email	matsuhm@faculty.chiba-u.jp

Public contact
Name of contact person	Masayuki Kano
Organization	Graduate School of Medicine, Chiba University
Division name	Department of Frontier Surgery
Address	1-8-1 Inohana,Chuo-Ku,Chiba,Chiba,JAPAN
TEL	043-226-2109
Homepage URL
Email	mkano@chiba-u.jp

Sponsor
Institute	Chiba University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	千葉大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 10 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 09 Month 26 Day
Anticipated trial start date	2016 Year 09 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	We will establish a consolidated database of genetic mutation results and clinical information of cancer patients who underwent clinical sequencing, and will promote domestic completion type cancer genome medicine and aim for improvement of treatment outcomes of cancer.

Management information
Registered date	2018 Year 09 Month 14 Day
Last modified on	2018 Year 09 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038850