UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025870 |
|---|---|
| Receipt number | R000029736 |
| Scientific Title | Clinical study for early diagnosis of cancer metastasis by exosomes in serum |
| Date of disclosure of the study information | 2017/01/28 |
| Last modified on | 2022/01/31 14:45:06 |
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Basic information
Public title
Clinical study for early diagnosis of cancer metastasis by exosomes in serum
Acronym
Early diagnosis of cancer metastasis by exosomes
Scientific Title
Clinical study for early diagnosis of cancer metastasis by exosomes in serum
Scientific Title:Acronym
Early diagnosis of cancer metastasis by exosomes
Region
| Japan |
Condition
Condition
sarcoma
Classification by specialty
| Orthopedics |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate metastatic risk of cancer patient by analysis of exosomes in serum
Basic objectives2
Others
Basic objectives -Others
Analyze exosomes of cancer patient before starting treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnostic accuracy of metastasis
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
| 5 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Diagnosed with malignancy
ECOG Performance Status 0to 3
5 years old or more
WBC over 2,000/mm3
Plt over 50,000/mm3
Hb over 8.0g/dl
Key exclusion criteria
severe heart disease, renal dyfunction, respiratory failure, caogulation disorder
double cancer
pregnant
Other medical, social, or psychological conditions that in the opinion of an investigator precludes the patient from appropriate consent
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Hayashi |
Organization
Kanazawa Univ
Division name
Orthopaedic department
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Japan
TEL
0762652374
khayashi830@gmail.com
Public contact
Name of contact person
| 1st name | Katsuhiro |
| Middle name | |
| Last name | Hayashi |
Organization
Kanazawa Univ
Division name
Orthopaedic department
Zip code
920-8641
Address
Takaramachi 13-1, Kanazawa, Japan
TEL
0762652374
Homepage URL
khayashi830@gmail.com
Sponsor or person
Institute
Kanazawa Univ
Institute
Department
Personal name
Funding Source
Organization
self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB Kanazawa Univ
Address
Takaramachi13-1, Kanazawa
Tel
0762652000
rinri@adm.kanazawa-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
| 2017 | Year | 01 | Month | 28 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients who are treated in Kanazawa Univ
Management information
Registered date
| 2017 | Year | 01 | Month | 27 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029736
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
