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AFP and AFP variant ratio (AFP-L3) assay kit (LBA) and prothrombin induced by vitamin K absence-II assay kit (LBA)

Diagnostic Values of Triple Biomarkers AFP, AFP-L3 and PIVKA-II in Patients with Hepatocellular Carcinoma

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900021893
Enrollment
Unknown
Registered
2019-03-15
Start date
2012-06-19
Completion date
Unknown
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatocellular carcinoma

Interventions

Gold Standard:Computed tomography (CT) or magnetic resonance imaging (MRI) showed typical features of HCC
or pathology or ultrasound-guided biopsies were performed for diagnosis of HCC
Clinical reference chose AFP quantitative detection assay kit (electrochemiluminescence).
Index test:AFP&#32
and&#32
AFP&#32
(AFP&#32
L3)&#32
kit&#32
(LBA)
by&#32
K&#32
Absence-II&#32
(PIVKA&#32

Sponsors

Beijing Friendship Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
14 Years to 87 Years

Inclusion criteria

Inclusion criteria: (1) Computed tomography (CT) or magnetic resonance imaging (MRI) showed typical features of HCC, and the nodule size was larger than 2 cm for patients with chronic hepatitis and liver cirrhosis. In some cases especially the hepatic nodule was smaller than 2 cm, pathology or ultrasound-guided biopsies were performed for diagnosis of HCC; (2) Newly diagnosed HCC without any treatment; (3) Agreed and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) HCC patients who have any other cancers than HCC, e.g. testicular cancer, gastrointestinal cancer; (2) Patients with recurrent HCC; (3) Pregnant women; (4) Patients who are being treated with warfarin.

Design outcomes

Primary

MeasureTime frame
alpha-fetoprotein;lectin-reactive fraction of alpha-fetoprotein (AFP-L3);prothrombin induced by vitamin K absence or antagonist-II;

Countries

China

Contacts

Public ContactJidong Jia

Liver Research Center, Beijing Friendship Hospital

jia_jd@ccmu.edu.cn+86 13501378269

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026