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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038273
Receipt No. R000043625
Scientific Title Elucidation of treatment-specific gene mutation by liquid biopsy in patients with soft tissue sarcomas
Date of disclosure of the study information 2019/12/01
Last modified on 2019/10/11

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Basic information
Public title Elucidation of treatment-specific gene mutation by liquid biopsy in patients with soft tissue sarcomas
Acronym Usefullness of liquid biopsy in patients with soft tissue sarcomas
Scientific Title Elucidation of treatment-specific gene mutation by liquid biopsy in patients with soft tissue sarcomas
Scientific Title:Acronym Usefullness of liquid biopsy in patients with soft tissue sarcomas
Region
Japan

Condition
Condition advanced soft tissue sarcomas
Classification by specialty
Orthopedics
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 The purpose of this study is to perform a liquid biopsy using blood samples from patients with advanced soft tissue sarcoma and to identify gene mutations that are therapeutic targets.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Identification of gene mutations to be treated
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria advanced soft tissue sarcoma
expected life expectancy more than 6 months
Performance status 0-2
Informed consent obtained
Key exclusion criteria Fresh tumor tissue could be obtained
Infomed consent not obtained
Performance status equal or more than 3
Target sample size 15

Research contact person
Name of lead principal investigator
1st name Yoshihiro
Middle name
Last name Nishida
Organization Nagoya University Hospital
Division name Rehabilitation Medicine
Zip code 466-8550
Address 65-Tsurumai, Showa, Nagoya
TEL 052-744-1908
Email ynishida@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Kunihiro
Middle name
Last name Ikuta
Organization Nagoya University Hospital
Division name Genome Medical Center
Zip code 466-8550
Address 65-Tsurumai, Showa, Nagoya
TEL 052-744-1908
Homepage URL
Email k-ikuta@med.nagoya-u.ac.jp

Sponsor
Institute Orthopaedic surgery, Nagoya University Hospital
Institute
Department

Funding Source
Organization Nagoya University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Nagoya University Hospital
Address 65-Tsurumai, Showa, Nagoya
Tel 052-741-2111
Email center@med.nagoya-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

Other administrative information
Date of disclosure of the study information
2019 Year 12 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 Preinitiation
Date of protocol fixation
2019 Year 11 Month 15 Day
Date of IRB
Anticipated trial start date
2019 Year 12 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information observational study: Usefulness of liquid biopsy for patients with advanced soft tissue sarcoma

Management information
Registered date
2019 Year 10 Month 11 Day
Last modified on
2019 Year 10 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043625

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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