UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007092 |
|---|---|
| Receipt number | R000008340 |
| Scientific Title | Evaluation of overexpression of VEGF-C mRNA of extrahepatic bile duct carcinoma using surgical and endoscopic samples obtained with biopsy or brushing cytology during endoscopic retrograde cholangiopancreatography |
| Date of disclosure of the study information | 2012/01/17 |
| Last modified on | 2013/05/28 18:30:37 |
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Basic information
Public title
Evaluation of overexpression of VEGF-C mRNA of extrahepatic bile duct carcinoma using surgical and endoscopic samples obtained with biopsy or brushing cytology during endoscopic retrograde cholangiopancreatography
Acronym
The expression of VEGF-C mRNA of extrahepatic bile duct cancer
Scientific Title
Evaluation of overexpression of VEGF-C mRNA of extrahepatic bile duct carcinoma using surgical and endoscopic samples obtained with biopsy or brushing cytology during endoscopic retrograde cholangiopancreatography
Scientific Title:Acronym
The expression of VEGF-C mRNA of extrahepatic bile duct cancer
Region
| Japan |
Condition
Condition
extrahepatic bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the overexpression of the VEGF-C mRNA of extrahepatic bile duct cancer using surgical and endoscopic specimens obtained with biopsy or brushing cytology during endoscopic retrograde cholangiopancreatography
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of VEGF-C of extrahepatic bile duct cancer using surgical and endoscopic samples
Key secondary outcomes
The expression of VEGFR-3,lymphovascular invasion, lymph node metastasis
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
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Evaluation of VEGF-C mRNA and protein
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.The patients who are suspected of extrahepatic bile duct cancer and have a plan to take the examination of ERCP.
2.Performance status; 0,1,2
Key exclusion criteria
1.The patients who take anticoagulants
2.The patients with acute pancreatitis
3.The patient who have already take chemotherapy or radiotherapy
4.The patients who are pregnant
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Akira Dobashi |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
3-25-8 Nishi Shinbashi, Minato-ku, Tokyo 105-8461, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
Address
TEL
Homepage URL
akira.dobashi@nifty.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Research fund of The Jikei University School of Medicine, Department of Endoscopy.
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
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
東京慈恵会医科大学
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The quantification of VEGF-C mRNA of extrahepatic cholangiocarcinom with real-time PCR using endoscopic samples was useful for pre-operative detection of VEGF-C overexpression.
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
Completed
Date of protocol fixation
| 2011 | Year | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 05 | Month | 28 | Day |
Date of closure to data entry
| 2013 | Year | 05 | Month | 28 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 28 | Day |
Date analysis concluded
| 2013 | Year | 05 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 01 | Month | 17 | Day |
Last modified on
| 2013 | Year | 05 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008340
