UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045714 |
|---|---|
| Receipt number | R000052183 |
| Scientific Title | Utility of DWI-MRI and histopathological evaluation on early response of HCC with molecular targeting therapy |
| Date of disclosure of the study information | 2021/10/11 |
| Last modified on | 2021/10/11 09:45:49 |
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Basic information
Public title
Utility of DWI-MRI and histopathological evaluation on early response of HCC with molecular targeting therapy
Acronym
Utility of DWI-MRI and histopathological evaluation on early response of HCC with molecular targeting therapy
Scientific Title
Utility of DWI-MRI and histopathological evaluation on early response of HCC with molecular targeting therapy
Scientific Title:Acronym
Utility of DWI-MRI and histopathological evaluation on early response of HCC with molecular targeting therapy
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 DWI-MRI, histopathological analysis, and exosome as biomarker on treatment response for HCC
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between DWI-MRI, histopathologic evaluation, and exosome and radiological response on RECIST 1.1
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
1. Equal or more than 20 years old
2. Histopathologic diagnosed as HCC
3. Nonresectable HCC
4. Patients with fully informed consent
Key exclusion criteria
1. Allergy with iodine contrast media
2. eGFR is less than 40ml/min
3. Child-Pugh is B and C
4. Not suitable for the study due to researcher's decision
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University
Division name
Dept. of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, NIshi-shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
sugimoto@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Katsutoshi |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Medical University
Division name
Dept. of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, NIshi-shinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
sugimoto@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Dept. of pathology, Keio University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University Institutional Review Board
Address
6-7-1, Nishi-shinjuku, Shinjuku-ku
Tel
03-3342-6111
adm_irb@tokyo-med.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
| 2021 | Year | 10 | Month | 11 | 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
Open public recruiting
Date of protocol fixation
| 2019 | Year | 12 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 07 | Month | 31 | Day |
Other
Other related information
Pathologic evaluations are performed at Keio University
Management information
Registered date
| 2021 | Year | 10 | Month | 11 | Day |
Last modified on
| 2021 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052183
