UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053279 |
|---|---|
| Receipt number | R000059978 |
| Scientific Title | Impact of systemic therapy on the serum vascular endothelial growth factor levels in patients with hepatocellular carcinoma after transarterial chemoembolization |
| Date of disclosure of the study information | 2024/01/05 |
| Last modified on | 2024/01/05 18:51:02 |
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Basic information
Public title
Impact of systemic therapy on the serum vascular endothelial growth factor levels in patients with hepatocellular carcinoma after transarterial chemoembolization
Acronym
Impact of systemic therapy on the serum vascular endothelial growth factor levels in patients with hepatocellular carcinoma after transarterial chemoembolization
Scientific Title
Impact of systemic therapy on the serum vascular endothelial growth factor levels in patients with hepatocellular carcinoma after transarterial chemoembolization
Scientific Title:Acronym
Impact of systemic therapy on the serum vascular endothelial growth factor levels in patients with hepatocellular carcinoma after transarterial chemoembolization
Region
| Japan |
Condition
Condition
hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the influence of systemic therapy to the serum vascular endothelial growth factor levels in patients with hepatocellular carcinoma after transarterial chemoembolization
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparing the amount of change in VEGF levels before and after Transarterial Chemoembolization for each systemic drug therapy
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with unresectable advanced hepatocellular carcinoma (HCC) who are scheduled for Transarterial Chemoembolization
Key exclusion criteria
exclusion criterion
1. Child-Pugh C patients:
2. Patients with esophageal varices that may cause bleeding
3. Patients with gastrointestinal bleeding within 1 month
4. Patients who are pregnant, may be pregnant, or are breastfeeding
5. Patients with severe hypersensitivity to the components of this drug
6. Patients with severe heart failure or renal failure
7. Patients with malignant tumors other than hepatocellular carcinoma
8. Other patients unsuitable as subjects by the research director
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | hisashi |
| Middle name | |
| Last name | hidaka |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa 252-0375, Japan
TEL
0427788111
hisashi7@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Haruki |
| Middle name | |
| Last name | Uojima |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
TEL
0427788111
Homepage URL
kiruha@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
Institutional Review Board of kitasato university
Address
1-15-1 Kitasato, Minami-ku, Sagamihara, Kanagawa
Tel
0427788111
rinrib@med.kitasato-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 05 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 09 | Month | 06 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2025 | Year | 07 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To compare the changes in VEGF levels after TAE for enrolled patients, VEGF was measured at three time points for each patient (before treatment, 3 days after treatment, and 56 days after treatment),
Management information
Registered date
| 2024 | Year | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059978
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
