HepatoblastomaPIVKA-IINCT03645655
PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants
An observational study of Hepatoblastoma and Hepatic Hemangioendothelioma, run by Shanghai Children's Medical Center at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 12 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatoblastoma, Hepatic Hemangioendothelioma
- What is being tested?
- PIVKA-II
- How many people
- 257 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: The participants will be recruited through inpatient department.
Who may be able to join
- Age between 1 month and 12 month
- Receiving no treatment before diagnosis
- With written informed consent
Who cannot join
- Clinical data missing
- Serum samples doesn't qualified
- Vitamin K absence
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Children's Medical Center, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200127
About this study
Official title: PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants: Protocol for a Multicenter, Observational Study
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.
Read the 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 hepatocellular (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.
- Conditions
- Hepatoblastoma, Hepatic Hemangioendothelioma
- Being tested
- PIVKA-II
- Keywords
- hepatoblastoma, Hepatic Hemangioendothelioma, Protein induced by vitamin K absence or antagonist-II, Alpha-fetoprotein, infant, Differential diagnosis
- Medical subject headings
- Hepatoblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PIVKA-IIDiagnostic test
Also called DCP
Serum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests.
| Study group | Role | What they receive |
|---|---|---|
| hepatoblastoma | The diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology. Receives: Diagnostic Test: PIVKA-II | |
| hepatic hemangioendothelioma | The diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology. Receives: Diagnostic Test: PIVKA-II | |
| Healthy control | The healthy control group consist of people undergoing routine medical examination. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of PIVKA-II
Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).
Measured: Baseline Time, Postoperative Day 1
Secondary outcomes (1)
Change of AFP
Using the AFP assay (ARCHITECT AFP, Abbott, America).
Measured: Baseline Time, Postoperative Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start1 Oct 2018
- Primary completion30 Sep 2020
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HepatoblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 257 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Children's Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Fudan University, Children's Hospital of 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, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Responsible party
- Sponsor
- Investigators
- Min Xu, Doctor, Study chair, Shanghai Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03645655
- Sponsor's protocol ID
- General surgery of SCMC
- Acronym
- PIVKA-II
- Status last verified
- Jul 2021
- First submitted
- 20 Aug 2018
- Last updated
- 23 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Gao H, Xie C, Wang J, Ma J, Liu S, Xie L, Zheng Y, Dong R, Wang S, Fang Y, Wu Y, Zhang X, Lu X, Li Y, Li W, Pan Q, Xu M, Gu S. PIVKA-II combined with alpha-fetoprotein for the diagnostic value of hepatic tumors in children: a multicenter, prospective observational study. Hepatol Int. 2024 Aug;18(4):1326-1335. doi: 10.1007/s12072-024-10668-4. Epub 2024 Apr 16.
PubMed 38622445
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PIVKA-II Combined With Alpha-Fetoprotein for Diagnostic and Prognostic Value of Hepatic Tumors in Infants: Protocol for a Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT03645655
- Acronym / sponsor ID
- PIVKA-II / General surgery of SCMC
- Conditions
- Hepatoblastoma, Hepatic Hemangioendothelioma
- Keywords
- hepatoblastoma, Hepatic Hemangioendothelioma, Protein induced by vitamin K absence or antagonist-II, Alpha-fetoprotein, infant, Differential diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 257 participants (actual)
- Lead sponsor
- Shanghai Children's Medical CenterUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Children's Hospital of Fudan University, Children's Hospital of 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, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 24 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 hepatocellular (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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| hepatoblastoma | – | Diagnostic Test: PIVKA-IIThe diagnosis of hepatoblastoma is based on enhanced CT scanning and/or histopathology. |
| hepatic hemangioendothelioma | – | Diagnostic Test: PIVKA-IIThe diagnosis of hepatic hemangioendothelioma is based on enhanced CT scanning and/or histopathology. |
| Healthy control | – | –The healthy control group consist of people undergoing routine medical examination. |
Who may qualify
- Ages
- 1 month to 12 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The participants will be recruited through inpatient department.
Key inclusion criteria (3 listed)
- Age between 1 month and 12 month
- Receiving no treatment before diagnosis
- With written informed consent
Key exclusion criteria (3 listed)
- Clinical data missing
- Serum samples doesn't qualified
- Vitamin K absence
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PIVKA-IIAlso: DCPSerum samples are tested for tumor markers including PIVKA-II, AFP, and biochemical tests. | Diagnostic test | hepatic hemangioendothelioma, hepatoblastoma |
Primary outcome
Change of PIVKA-II
Time frame: Baseline Time, Postoperative Day 1
Using PIVKA-II assay kit (ARCHITECT I2000SR REFURB, Abbott, America).
1 secondary outcome
Change of AFP
Time frame: Baseline Time, Postoperative Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2021.
- Derived from this study: PubMed 38622445Gao H, Xie C, Wang J, Ma J, Liu S, Xie L, Zheng Y, Dong R, Wang S, Fang Y, Wu Y, Zhang X, Lu X, Li Y, Li W, Pan Q, Xu M, Gu S. PIVKA-II combined with alpha-fetoprotein for the diagnostic value of hepatic tumors in children: a multicenter, prospective observational study. Hepatol Int. 2024 Aug;18(4):1326-1335. doi: 10.1007/s12072-024-10668-4. Epub 2024 Apr 16.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Min Xu, Doctor study chair
Shanghai Children's Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatoblastoma and Hepatic Hemangioendothelioma, run by Shanghai Children's Medical Center at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of PIVKA-II (time frame: Baseline Time, Postoperative Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03645655, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2021.