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Clinical trial of abnormal prothrombin (PIVKA-II) assay kit (magnetic particle chemiluminescence method)

Clinical trial of abnormal prothrombin (PIVKA-II) assay kit (magnetic particle chemiluminescence method)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100048500
Enrollment
Unknown
Registered
2021-07-09
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-03-21

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

Conditions

primary liver cancer

Interventions

Gold Standard:histopathology or cytology
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Sponsors

Shandong Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. The source of the remaining serum/plasma samples from the daily inspection of the hospital can be traced; 2. Visually observe that the appearance of serum samples is clear and transparent, and the appearance of plasma samples is light yellow and translucent, and there is no turbidity or insoluble matter visible to the naked eye; 3. The PIVKA-II content of the selected samples should cover the detection range of the reagent [5,75000] mAU/mL, covering the samples of intended use; 4. The sample volume is sufficient (not less than 500 uL), the age is over 18 years old, and the gender is not limited. It can include samples such as mild hemolysis, lipemia, and jaundice.

Exclusion criteria

Exclusion criteria: 1. Severe hemolysis, severe lipemia, severe jaundice; 2. Samples with too many normal values or abnormal values within a certain range; 3. Duplicate samples; 4. Samples that have been repeatedly frozen and thawed; 5. Those with insufficient sample size due to operational errors during the test.

Design outcomes

Primary

MeasureTime frame
abnormal prothrombin;

Countries

China

Contacts

Public ContactXie Li

Shandong Cancer Hospital

1029355211@qq.com+86 15563360367

Outcome results

None listed

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