UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025989 |
|---|---|
| Receipt number | 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 14:02:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
tsukoba@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima university
Institute
Department
Personal name
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
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
Value
https://center6.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 |
