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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000045714
Receipt No. 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

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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
Email 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
Email sugimoto@tokyo-med.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052183

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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