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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000027988
Receipt No. 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 2017/06/29

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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
Middle name
Last name Takuji Torimura
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan
TEL 0942-31-7561
Email tori@med.kurume-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hironori Koga
Organization Kurume University School of Medicine
Division name Division of Gastroenterology, Department of Medicine
Zip code
Address 67 Asahi-machi, Kurume 830-0011, Japan
TEL 0942-31-7746
Homepage URL
Email hirokoga@med.kurume-u.ac.jp

Sponsor
Institute Kurume University
Institute
Department

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
Address
Tel
Email

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 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 Enrolling by invitation
Date of protocol fixation
2017 Year 03 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Under recruiting patients

Management information
Registered date
2017 Year 06 Month 29 Day
Last modified on
2017 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031329

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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