Skip to content

Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma

Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma - Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000051084
Enrollment
530
Registered
2023-05-17
Start date
2023-01-17
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Hepatocellular carcinoma

Interventions

None listed

Sponsors

Tottori University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Select patients who meet all of the following Patients whose consent is obtained in writing 1)Male or female, age 20 years or older at the time of obtaining consent. 2)Must be diagnosed with hepatocellular carcinoma by imaging or histological examination. Patients who opt out 1)Men and women 20 years of age or older at the time of diagnosis. 2)Hepatocellular carcinoma diagnosed by imaging or histological examination.

Exclusion criteria

Exclusion criteria: Patients whose consent is to be obtained in writing 1) Patients with primary tumors of other organs 2) PIVKA-II false positive patients with elevated PIVKA-II due to taking warfarin or using antibiotics within 1 month, or PIVKA-II false negative patients on vitamin K replacement therapy Opt-out patients 1) Patients with primary tumors of other organs 2) PIVKA-II false-positive patients with elevated PIVKA-II due to taking warfarin or using antibiotics within a month, or PIVKA-II false-negative patients on vitamin K replacement therapy 3) Patients who have refused to allow the use of data collected from their medical information records.

Design outcomes

Primary

MeasureTime frame
This study aims to evaluate the efficacy of GOLM1 (Golgi protein 73; GP73), Replication Protein A 3 (RPA3), Stomatin Like 2 (STOML2), Glipican 3, Midkine (MDK), Dkk-1, Heat shock protein 70 (Hsp70), Osteopontin, Squamous cell carcinoma antigen (SCCA), and CA 125 as potential biomarkers in HCC patients with DNHC. Blood samples were collected at the time of diagnosis or before and after treatment (up to four time points, regardless of treatment modality).

Secondary

MeasureTime frame
Utilizing our comprehensive database of first-episode liver cancer, we intend to conduct an assessment of the clinical features and prognosis, including recurrence and survival outcomes, in patients with DNHC in comparison to individuals diagnosed with AFP or PIVKA-II positive HCC. Additionally, we will investigate the disparities in biomarker variability and prognosis between patients with AFP or PIVKA-II positive HCC and those with DNHC. To achieve this, blood samples will be collected prior to and following treatment, as specified in the primary endpoints."

Countries

Japan

Contacts

Public ContactTAKAAKI SUGIHARA

Tottori University Hospital Tottori University Hospital

sugitaka@tottori-u.ac.jp0859-38-6527

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026