Clinical trial · Observational
Prospective Surveillance for Very Early Hepatocellular Carcinoma
Prospective Surveillance for Very Early Hepatocellular Carcinoma (PRECAR): an Observational Cohort Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatocellular carcinoma is one the leading cause of increasing cancer-specific mortality worldwide. Early diagnosis of hepatocellular carcinoma provides opportunity for curative therapeutic approaches and relatively favorable prognosis. Herein, we intended to establish a biosignature for early diagnosis of hepatocellular carcinoma and stratification of risk population for intensive follow-up by implementing biannual follow-up investigation and collecting peripheral blood samples for screening.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Carcinoma, Hepatocellular | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Cirrhosis cohort
- description
- Patients with liver cirrhosis.
- label
- HBV infection cohort
- description
- Patients with seropositivity of HBsAg.
Primary outcomes (3)
- measure
- Hepatocellular carcinoma
- timeFrame
- July 2018 to July 2022
- description
- Development of hepatocellular carcinoma
- measure
- Overall survival
- timeFrame
- July 2018 to July 2022
- description
- Death
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 30 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria:
\-
\[1\] Cirrhosis cohort
1. Age within 30 to 75 years.
2. Diagnosis of liver cirrhosis within recent 6 months.
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1. Liver biopsy: Metavir score of 4 or Ishak score of 5 to 6.
2. No liver biopsy: Presence of ascites, hepatic encephalopathy, or variceal hemorrhage.
3. Satisfying equal to or more than 2 of below conditions.
* Imaging studies indicating characteristics of liver cirrhosis: irregular liver surface, liver parenchyma particles or nodules, intraperitoneal collateral circulation, or varicose veins with or without splenomegaly (more than 4 cm or 5 ribs).
* Platelet count \< 200 x 10\^9/L.
* Alanine aminotransferase \< 5 folds of normal level and liver hardness \> 12 kPa.
* Gastroesophageal varices from endoscopy or imaging studies.
\[2\] HBV infection cohort
1. Age within 40 to 70 years
2. Chronic HBV infection (seropositive for HBsAg over 6 months).
Exclusion Criteria:
1. Cirrhosis cohort
(1) Child-Pugh score of C.
(2) Hereditary metabolic liver diseases.
(3) Presence of HIV-Ab.
(4) Previous diagnosis of active pulmonary tuberculosis.
(5) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.
(6) Patients who had received allogeneic blood transfusion or cell therapy within 1 year.
(7) Pregnant women.
\[2\] HBV infection cohort
(1) Autoimmune liver diseases.
(2) Hereditary metabolic liver diseases.
(3) Other chronic liver diseases, such as flukes.
(4) Presence of HCV, HDV, HEV, or HIV infection.
(5) Previous diagnosis of active pulmonary tuberculosis.
(6) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma.
(7) Patients who had received allogeneic blood transfusion or cell therapy within 1 year.
(8) Pregnant women.References
Publications (1)
- DERIVEDXing X, Cai L, Ouyang J, Wang F, Li Z, Liu M, Wang Y, Zhou Y, Hu E, Huang C, Wu L, Liu J, Liu X. Proteomics-driven noninvasive screening of circulating serum protein panels for the early diagnosis of hepatocellular carcinoma. Nat Commun. 2023 Dec 18;14(1):8392. doi: 10.1038/s41467-023-44255-2. PMID 38110372