UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038273 |
|---|---|
| Receipt number | 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 | 2024/10/15 21:50:11 |
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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
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
k-ikuta@med.nagoya-u.ac.jp
Sponsor or person
Institute
Orthopaedic surgery, Nagoya University Hospital
Institute
Department
Personal name
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
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
15
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Delay in data analyses.
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2024 | Year | 04 | Month | 01 | Day |
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043625
