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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

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.

Condition or disease Intervention/treatment
Hepatoblastoma Hepatic Hemangioendothelioma Diagnostic Test: PIVKA-II

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.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Diagnostic and Differential Diagnostic Accuracy of PIVKA-II Combining With Alpha-Fetoprotein in Hepatic Tumor of Infant
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

Group/Cohort Intervention/treatment
hepatoblastoma
The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology.
Diagnostic Test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
Other Name: DCP

hepatic hemangioendothelioma
The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology.
Diagnostic Test: PIVKA-II
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
Other Name: DCP

Healthy control
The healthy control group consist of people undergoing routine medical examination.



Primary Outcome Measures :
  1. Change of PIVKA-II [ Time Frame: Baseline Time, Postoperative Day 1 ]
    Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).


Secondary Outcome Measures :
  1. Change of AFP [ Time Frame: Baseline Time, Postoperative Day 1 ]
    Using the AFP assay (ARCHITECT AFP, Abbott, America).



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The participants will be recruited through inpatient department.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03645655


Contacts
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Contact: Min Xu, Doctor +86-18930830805 xumin@scmc.com.cn
Contact: Hongxiang Gao, Master +86-15216606578 guyafeihong@163.com

Locations
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China, Shanghai
Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine Recruiting
Shanghai, Shanghai, China, 200127
Contact: Min Xu, Doctor         
Sponsors and Collaborators
Shanghai Children's Medical Center
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
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Study Chair: Min Xu, Doctor Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine

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Responsible Party: Shanghai Children's Medical Center
ClinicalTrials.gov Identifier: NCT03645655     History of Changes
Other Study ID Numbers: General surgery of SCMC
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Children's Medical Center:
hepatoblastoma
Hepatic Hemangioendothelioma
Protein induced by vitamin K absence or antagonist-II
Alpha-fetoprotein
infant
Differential diagnosis
Additional relevant MeSH terms:
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Hepatoblastoma
Liver Neoplasms
Hemangioendothelioma
Neoplasms, Complex and Mixed
Neoplasms by Histologic Type
Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Hemangioma
Neoplasms, Vascular Tissue