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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034153
Receipt No. R000038850
Scientific Title Integrated database construction of genomic information and clinical information obtained by clinical sequence
Date of disclosure of the study information 2018/10/01
Last modified on 2018/09/14

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Basic information
Public title Integrated database construction of genomic information and clinical information obtained by clinical sequence
Acronym Integrated database construction of genomic information and clinical information obtained by clinical sequence
Scientific Title Integrated database construction of genomic information and clinical information obtained by clinical sequence
Scientific Title:Acronym 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
1st name
Middle name
Last name Hisahiro Matsubara
Organization Graduate School of Medicine, Chiba University
Division name Department of Frontier Surgery
Zip code
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
1st name
Middle name
Last name Masayuki Kano
Organization Graduate School of Medicine, Chiba University
Division name Department of Frontier Surgery
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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
2016 Year 09 Month 26 Day
Date of IRB
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

Other
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

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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