UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033269 |
|---|---|
| Receipt number | R000037931 |
| Scientific Title | Exploratory research of liquid biopsy for patients with cancer |
| Date of disclosure of the study information | 2018/07/04 |
| Last modified on | 2019/01/04 18:35:26 |
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Basic information
Public title
Exploratory research of liquid biopsy for patients with cancer
Acronym
Liquid biopsy for cancer
Scientific Title
Exploratory research of liquid biopsy for patients with cancer
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Hitoshi Zembutsu |
Organization
Cancer Institute
Division name
Cancer Precision Medicine Center
Zip code
Address
3-8-1, Ariake, koto-ku, Tokyo
TEL
03-3570-0509
hitoshi.zembutsu@jfcr.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Zembutsu |
Organization
Cancer Institute
Division name
Cancer Precision Medicine Center
Zip code
Address
3-8-1, Ariake, koto-ku, Tokyo
TEL
03-3570-0509
Homepage URL
hitoshi.zembutsu@jfcr.or.jp
Sponsor or person
Institute
Cancer Precision Medicine Center
Cancer Institute,
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2017 | Year | 06 | Month | 20 | Day |
Date of IRB
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
Other
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
| 2019 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037931
| 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 |
