UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027988 |
|---|---|
| Receipt number | R000031329 |
| Scientific Title | Analysis of liver cancer development in patients who showed sustained viral response to chronic hepatitis C virus infection by receiving direct acting-antiviral therapy, a prospective multicenter study |
| Date of disclosure of the study information | 2017/07/03 |
| Last modified on | 2019/12/31 11:51:23 |
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Basic information
Public title
Analysis of liver cancer development in patients who showed sustained viral response to chronic hepatitis C virus infection by receiving direct acting-antiviral therapy, a prospective multicenter study
Acronym
A prospective multicenter study on hepatocarcinogenesis after DAA-induced SVR for HCV
Scientific Title
Analysis of liver cancer development in patients who showed sustained viral response to chronic hepatitis C virus infection by receiving direct acting-antiviral therapy, a prospective multicenter study
Scientific Title:Acronym
A prospective multicenter study on hepatocarcinogenesis after DAA-induced SVR for HCV
Region
| Japan |
Condition
Condition
Hepatitis C virus-related chronic liver diseases
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To elucidate liver cancer incidence and prognosis in HCV-infected patients showing SVR after DAA treatment.
Basic objectives2
Others
Basic objectives -Others
To elucidate time to liver cancer occurrence and the cancer characteristics, including tumor size, number of tumor, gross appearance, location, vascular invasion, and tumor markers.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Characteristics of liver cancer developed after DAA-induced SVR (tumor size, number of tumor, gross appearance, location, vascular invasion, and tumor markers)
Key secondary outcomes
1) Patient characteristics and background liver when liver caner occurs
2) Liver cancer incidence
3)Possible inhibitory effect of SVR on liver cancer recurrence in patients receiving curative therapy for primary liver cancer
4) Patients' prognosis
5) Adverse effects of DAA treatments
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) 20 years old of age or more
2) HCVRNA-positive results prior to DAA treatment
3) Curative treatment for patients who had HCC
4) Informed consent for DAA treatments
5) Eligible for each DAA used in this study
Key exclusion criteria
1) (Potentially) pregnant woman and lactating woman
2) Allergic reaction for DAAs and biological agents including vaccines
3) Difficult-to-control heart diseases
4) Severe liver injury, including Child-Pugh class B and C
5) Contraindicated drugs for combination with DAAs
6) Uncontrolled diabetes mellitus
7) Inappropriate patients who are judged by study-managing doctors
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Takuji |
| Middle name | |
| Last name | Torimura |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan
TEL
0942-31-7561
tori@med.kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Hironori |
| Middle name | |
| Last name | Koga |
Organization
Kurume University School of Medicine
Division name
Division of Gastroenterology, Department of Medicine
Zip code
830-0011
Address
67 Asahi-machi, Kurume 830-0011, Japan
TEL
0942-31-7746
Homepage URL
hirokoga@med.kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Kyushu Liver Cancer Study Group
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
Clinical Research Center, Kurume University Hospital
Address
67 Asahi-machi, Kurume 830-0011, Japan
Tel
0942-31-7200
kcrc_jimu@kurume-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
長崎大学大学院医歯薬学総合研究科展開医療科学講座（長崎県）、長崎医療センター臨床研究センター（長崎県）、佐賀大学医学部肝臓･糖尿病･内分泌内科（佐賀県）、九州医療センター肝胆膵外科（福岡県）、九州医療センター消化器科（福岡県）、福岡赤十字病院肝臓内科（福岡県）、福岡徳州会病院肝臓内科（福岡県）、産業医科大学第三内科（福岡県）、大分大学消化器内科（大分県）、大分医療センター消化器内科（大分県）、長崎労災病院消化器科（長崎県）、熊本大学消化器内科（熊本県）、宮崎大学内科学二（宮崎県）、南風病院肝臓内科（鹿児島県）、琉球大学第一内科（沖縄県）、鹿児島大学消化器内科（鹿児島県）、福岡大学消化器内科（福岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
3011
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
Main results already published
Date of protocol fixation
| 2017 | Year | 03 | Month | 08 | Day |
Date of IRB
| 2017 | Year | 03 | Month | 08 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Main results already published
Management information
Registered date
| 2017 | Year | 06 | Month | 29 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031329
| Research Plan | |
|---|---|
| Registered date | File name |
| 2019/12/31 | DAA後HCC-実施計画書・最終.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2019/12/31 | SVR-A-癌なし.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2019/12/31 | Ide, Koga; Hepatol Int 2019.pdf |
