UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017448 |
|---|---|
| Receipt number | R000020092 |
| Scientific Title | A product of alpha-fetoprotein and protein induced by vitamin K absence-II is a powerful predictor of prognosis and recurrence in hepatocellular carcinoma patients after a hepatectomy |
| Date of disclosure of the study information | 2015/05/11 |
| Last modified on | 2015/05/07 14:53:22 |
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Basic information
Public title
A product of alpha-fetoprotein and protein induced by vitamin K absence-II is a powerful predictor of prognosis and recurrence in hepatocellular carcinoma patients after a hepatectomy
Acronym
AP-factorHCC
Scientific Title
A product of alpha-fetoprotein and protein induced by vitamin K absence-II is a powerful predictor of prognosis and recurrence in hepatocellular carcinoma patients after a hepatectomy
Scientific Title:Acronym
AP-factorHCC
Region
| Japan |
Condition
Condition
Between January 1998 and December 2010, 516 consecutive adult patients underwent a hepatectomy for HCC at our center.
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the oncological implications of a product of alpha-fetoprotein (AFP) and protein induced by Vitamin K absence or antagonists-II (PIVKA-II) in patients with hepatocellular carcinoma (HCC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
AP-factor (AFP X PIVKA-II) was evaluated in relation to 2-year survival outcomes by receiver operating characteristics (ROC) analysis to determine the cut-off values. Patient survival, recurrence-free survival and risk factors were analyzed in accordance with the preoperative AP-factor.
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
| 18 | years-old | < |
Age-upper limit
| 88 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
hepatectomized patients
Key exclusion criteria
without hepatectomy
Target sample size
516
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshiya Kamiyama |
Organization
Hokkaido University
Division name
Gastroenterological Surgery I
Zip code
Address
N-15, W-7, Kita-ku, Sapporo
TEL
011-706-592
t-kamiya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshiya Kamiyama |
Organization
Hokkaido University
Division name
Gastroenterological Surgery I
Zip code
Address
N-15, W-7, Kita-ku, Sapporo
TEL
+81117065927
Homepage URL
t-kamiya@med.hokudai.ac.jp
Sponsor or person
Institute
Gastroenterological Surgery I
Institute
Department
Personal name
Funding Source
Organization
Gastroenterological Surgery I
Organization
Division
Category of Funding Organization
Other
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
| 2015 | Year | 05 | Month | 11 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Main results already published
Date of protocol fixation
| 2013 | Year | 05 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 05 | Month | 23 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
AP-factor (product of alpha-fetoprotein and protein induced by vitamin K absence or antagonism factor II) may be more reliable prognostic marker of survival and recurrence of patients who underwent hepatectomy for hepatocellular carcinoma.
Management information
Registered date
| 2015 | Year | 05 | Month | 07 | Day |
Last modified on
| 2015 | Year | 05 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020092
