UMIN-CTR Clinical Trial

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
Email	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
Email	khayashi830@gmail.com

Sponsor
Institute	Kanazawa Univ
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000029736