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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000025989
Receipt No. R000029878
Scientific Title A study on the detection of circulating tumor cells (CTCs) in patients with hepatocellular carcinoma and its clinical significance
Date of disclosure of the study information 2017/02/03
Last modified on 2017/02/03

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Basic information
Public title A study on the detection of circulating tumor cells (CTCs) in patients with hepatocellular carcinoma and its clinical significance
Acronym CTC detection in HCC patients
Scientific Title A study on the detection of circulating tumor cells (CTCs) in patients with hepatocellular carcinoma and its clinical significance
Scientific Title:Acronym CTC detection in HCC patients
Region
Japan

Condition
Condition Hepatocellular carcinoma
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Purpose of this feasibility study is development of detection system for circulating tumor cells (CTCs) targeting glypican-3 in peripheral, portal and hepatic vein blood of hepatocellular carcinoma (HCC) patients. In addition, we evaluate whether the detected CTCs serve as a diagnosis of HCC, determination of medical treatment policies and prognostic factors.
Basic objectives2 Others
Basic objectives -Others Detection
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Glypican-3 positive CTC positivity rate for HCC patients
Key secondary outcomes Relationship of the CTC positivity rate with postoperative recurrence and prognosis

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Maneuver
Interventions/Control_1 Peripheral, portal and hepatic vein blood samples will be drawn from HCC patients during surgery and will be tested for CTC enumeration.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients who are going to undergo hepatectomy for HCC
2) Patients who personally have given informed consent in writing
Key exclusion criteria 1) History of active double cancer
2) Patients likely to be unable to personally give written informed consent and any other condition that the investigator feels would be inadequate for the safe conduct of this study
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Ohdan
Organization Hirohshima university
Division name Department of Gastroenterological and Transplant Surgery
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL 082-257-5220
Email hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuyoshi Kobayashi
Organization Hirohshima university
Division name Department of Gastroenterological and Transplant Surgery
Zip code
Address 1-2-3, Kasumi, Minami-ku, Hiroshima, Japan
TEL 082-257-5220
Homepage URL
Email tsukoba@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima university
Institute
Department

Funding Source
Organization This work was supported by Grant-in-Aid for Scientific Research(C)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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 広島大学病院(広島県)

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 03 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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 04 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

Management information
Registered date
2017 Year 02 Month 03 Day
Last modified on
2017 Year 02 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029878

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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