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Diagnostic Accuracy of PIVKA-II Combining With Alpha-Fetoprotein in Hepatic Tumor (PIVKA-II)

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ClinicalTrials.gov Identifier: NCT03645655
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Chidren's Hospital of Fudan University
Chongqing Children's Hospital, Chongqing Medical University
Children’s Hospital of Nanjing Medical University
Qilu Children's Hospital of Shandong University
Anhui Children's Hospital
The First Affiliated Hospital of Anhui Medical University
Zhengzhou Children's Hospital
Information provided by (Responsible Party):
Shanghai Children's Medical Center

Tracking Information
First Submitted Date August 20, 2018
First Posted Date August 24, 2018
Last Update Posted Date July 12, 2019
Actual Study Start Date October 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 22, 2018)
Change of PIVKA-II [ Time Frame: Baseline Time, Postoperative Day 1 ]
Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03645655 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: August 22, 2018)
Change of AFP [ Time Frame: Baseline Time, Postoperative Day 1 ]
Using the AFP assay (ARCHITECT AFP, Abbott, America).
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Diagnostic Accuracy of PIVKA-II Combining With Alpha-Fetoprotein in Hepatic Tumor
Official Title Diagnostic and Differential Diagnostic Accuracy of PIVKA-II Combining With Alpha-Fetoprotein in Hepatic Tumor of Infant
Brief Summary Although hepatic tumors are uncommon in the perinatal period they are associated with significant morbidity and mortality in affected patients. The study is intended to evaluate the diagnostic efficiency of Protein Induced by Vitamin K Absence or antagonist-II(PIVKA-II) combining with alpha-fetoprotein in hepatic tumor of infant. This study is a multicenter study joined by several hospitals in China. Participants including hepatoblastoma, hepatic hemangioendothelioma and healthy control are consecutively recruited into the cohort. All the serum samples are collected before and after each treatment and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, alpha-fetoprotein and biochemical indexes including alanine aminotransferase(ALT), aspartate aminotransferase(AST), gamma-glutamyl transferase(GGT), alpha-l-fucosidase(AFU), etc.
Detailed Description

Hepatic tumors seldom occur in the perinatal period. They comprise approximately 5% of the total neoplasms of various types occurring in the fetus and neonate. Infantile hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma. Although alpha-fetoprotein has been well recognized as biomarker of hepatic tumors, it should be mentioned that this protein in normal infants is highly elevated during the first 2 months of life.

Protein induced by vitamin K antagonist-II (PIVKA-II), also known as des-γ-carboxyprothrombin (DCP) or acarboxy prothrombin, is an abnormal form of prothrombin induced by vitamin K absence or antagonist-II. An elevated serum level of PIVKA-II is reported to be associated with HCC. Many studies have shown that PIVKA-II is applicable for HCC surveillance and has been written into the guideline of JSH, which achieves remarkably good results.

The study is intended to evaluate diagnostic and differential diagnostic accuracy of PIVKA-II combining with alpha-fetoprotein in hepatic tumor of infant.

This study is a multicenter study joined by several hospitals in China. Participants including hepatoblastoma, hepatic hemangioendothelioma and healthy control. All the serum samples are collected before and after each treatment and will be tested in single center in order to decrease bias. Serum samples were tested for PIVKA-II, Alpha-fetoprotein(AFP), and biochemical indexes including ALT, AST, GGT, AFU, etc. The diagnosis of hepatoblastoma and hepatic hemangioendothelioma was based on enhanced CT scanning and/or histopathology. The Student's t-test (or Mann-Whitney test) was used to compare continuous variables, and the chi-square test (or Fisher's exact test) was used for categorical variables. A receiver operator characteristic (ROC) curve was used to assess the diagnostic and differential diagnostic efficiency of PIVKA-II and the combined tumor markers with AFP.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population The participants will be recruited through inpatient department.
Condition
  • Hepatoblastoma
  • Hepatic Hemangioendothelioma
Intervention Diagnostic Test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
Other Name: DCP
Study Groups/Cohorts
  • hepatoblastoma
    The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology.
    Intervention: Diagnostic Test: PIVKA-II
  • hepatic hemangioendothelioma
    The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology.
    Intervention: Diagnostic Test: PIVKA-II
  • Healthy control
    The healthy control group consist of people undergoing routine medical examination.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 22, 2018)
200
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 30, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Age between 1 month and 12 month
  • Receiving no treatment before diagnosis
  • With written informed consent

Exclusion Criteria:

  • Clinical data missing
  • Serum samples doesn't qualified
  • Vitamin K absence
Sex/Gender
Sexes Eligible for Study: All
Ages 1 Month to 12 Months   (Child)
Accepts Healthy Volunteers Yes
Contacts
Contact: Min Xu, Doctor +86-18930830805 xumin@scmc.com.cn
Contact: Hongxiang Gao, Master +86-15216606578 guyafeihong@163.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT03645655
Other Study ID Numbers General surgery of SCMC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Shanghai Children's Medical Center
Study Sponsor Shanghai Children's Medical Center
Collaborators
  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  • Chidren's Hospital of Fudan University
  • Chongqing Children's Hospital, Chongqing Medical University
  • Children’s Hospital of Nanjing Medical University
  • Qilu Children's Hospital of Shandong University
  • Anhui Children's Hospital
  • The First Affiliated Hospital of Anhui Medical University
  • Zhengzhou Children's Hospital
Investigators
Study Chair: Min Xu, Doctor Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
PRS Account Shanghai Children's Medical Center
Verification Date August 2018