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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000027801 |
Receipt No. | R000031854 |
Scientific Title | The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan |
Date of disclosure of the study information | 2017/07/01 |
Last modified on | 2017/06/18 |
Basic information | ||
Public title | The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan | |
Acronym | The prognosis of older HCV patients in the North area of Kyoto, Japan | |
Scientific Title | The prognosis of older patients treated about the chronic hepatitis C in the North area of Kyoto, Japan | |
Scientific Title:Acronym | The prognosis of older HCV patients in the North area of Kyoto, Japan | |
Region |
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Condition | ||
Condition | Chronic Hepatitis C | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | The purpose of this study is to be clear the carcinogenesis of HCC, the background, the change of liver function, the direct cause of death of the older patients after treated the chronic hepatitis C. |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Cumulative carcinogenic rate |
Key secondary outcomes | SVR rate, the Over all survival, Recurrence rate, the transition of liver function, liver fibrosis, The event related liver disease and cardiovascular disease. |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | The objects are 65 years or higher patients treated the chronic hepatitis C in our hospital. | |||
Key exclusion criteria | none | |||
Target sample size | 150 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | The North Center of Kyoto prefectural university of medicine | ||||||
Division name | Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | 481 Otokoyama Yosanocho Yosagun, Kyoto, Japan | ||||||
TEL | 0772-46-3371 | ||||||
chiroinu@koto.kpu-m.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | The North Center of Kyoto prefectural university of medicine | ||||||
Division name | Gastroenterology and Hepatology | ||||||
Zip code | |||||||
Address | 481 Otokoyama Yosanocho Yosagun, Kyoto, Japan | ||||||
TEL | 0772-46-3371 | ||||||
Homepage URL | |||||||
chiroinu@koto.kpu-m.ac.jp |
Sponsor | |
Institute | Kyoto prefectural university of medicine |
Institute | |
Department |
Funding Source | |
Organization | none |
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 | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information | The objects are the 65 years or higher patients who treated the chronic hepatitis C from April 2014. The observation period is 12 years until March 2026. |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031854 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |