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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033269
Receipt No. R000037931
Official scientific title of the study Exploratory research of liquid biopsy for patients with cancer
Date of disclosure of the study information 2018/07/04
Last modified on 2018/07/04

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Basic information
Official scientific title of the study Exploratory research of liquid biopsy for patients with cancer
Title of the study (Brief title) Liquid biopsy for cancer
Region
Japan

Condition
Condition cancer
Classification by specialty
Not applicable
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To examine the feasibility and utility of liquid biopsy (ctDNA detection) for detection of cancer in early stage, monitoring of tumor recurrence, tumor response to anti-cancer therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes detection of somatic mutation in cfDNA
Key secondary outcomes time-course change in ctDNA

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
200 years-old >=
Gender Male and Female
Key inclusion criteria Patients who satisfy the below
1)Pathologically diagnosed as caner
2)20 or more years old
3)patients who understand and agree with the enrollment of this study with IC form.
Key exclusion criteria Patients who do not satisfy the inclusion criteria
Target sample size 800

Research contact person
Name of lead principal investigator Hitoshi Zembutsu
Organization Cancer Institute
Division name Cancer Precision Medicine Center
Address 3-8-1, Ariake, koto-ku, Tokyo
TEL 03-3570-0509
Email hitoshi.zembutsu@jfcr.or.jp

Public contact
Name of contact person Hitoshi Zembutsu
Organization Cancer Institute
Division name Cancer Precision Medicine Center
Address 3-8-1, Ariake, koto-ku, Tokyo
TEL 03-3570-0509
Homepage URL
Email hitoshi.zembutsu@jfcr.or.jp

Sponsor
Institute Cancer Precision Medicine Center
Cancer Institute,
Institute
Department

Funding Source
Organization KAKENHI, JSPS
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization JAPAN

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

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 がん研究会

Other administrative information
Date of disclosure of the study information
2018 Year 07 Month 04 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 20 Day
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information The result of this study will be reported in meeting or papers.

Management information
Registered date
2018 Year 07 Month 04 Day
Last modified on
2018 Year 07 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037931

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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