UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034153 |
|---|---|
| Receipt number | 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 19:12:08 |
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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 | Obstetrics 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
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
mkano@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038850
