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A prospective clinical study for circulating tumor DNA served as early diagnosis and prognosis biomarker of hepatocellular carcinoma patients

A prospective clinical study for circulating tumor DNA served as early diagnosis and prognosis biomarker of hepatocellular carcinoma patients

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1900023147
Enrollment
Unknown
Registered
2019-05-13
Start date
2019-05-15
Completion date
Unknown
Last updated
2019-05-20

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:Pathological examination
tumor&#32

Sponsors

Mengchao Hepatobiliary Hospital of Fujian Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Hepatitis B patient (1) Aged 18 (inclusive) to 70 years old (inclusive), male or female; (2) Previously diagnosed as chronic HBV infection (ie, HBsAg positive = 6 months). 2. Patients with chronic cirrhosis (1) Aged 18 (inclusive) to 75 years old (inclusive), male or female; (2) The results of the examination within the last six months are according with the diagnostic criteria for cirrhosis as specified in this study (see Section 7 - Variable Definitions for details). 3. HCC patients: (1) Aged 18 (inclusive) to 75 years old (inclusive), male or female; (2) The results of the examination within the last six months are according with the diagnostic criteria for HCC as specified in this study; (3) Acceptable standard clinical treatment plan for liver cancer such as surgery, TACE or targeted therapy.

Exclusion criteria

Exclusion criteria: 1. Hepatitis B patients Identify other causes of liver disease, including but not limited to: (1) autoimmune liver disease (PBC, PSC, AIH, IgG4-related liver disease, etc.); (2) Inherited metabolic liver disease (hepatic nucleus degeneration, etc.); (3) Other clear chronic liver diseases (schistosomiasis, liver disease, etc.): 1) Patients with HCV, HDV, HEV, HIV infection; 2) Previously diagnosed active tuberculosis; 3) Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma; 4) Patients who have received allogeneic blood transfusion or cell therapy within 1 year; 5) pregnant women; 6) Other liver diseases of unknown cause. 2. Patients with chronic cirrhosis: (1) Current Child-Pugh patients with grade C; (2) Previous examination results suggest patients with cirrhosis induced by other causes: 1) Inherited metabolic liver disease (hepatolenticular degeneration, etc.); 2) Clear chronic liver disease (schistosomiasis, liver disease, etc.). HIV-Ab+; Previously diagnosed active tuberculosis; Diagnosis of malignant tumors before or during hospitalization, including but not limited to hepatocellular carcinoma; Patients who have received allogeneic blood transfusion or cell therapy within 1 year; pregnant women; 3. HCC patients: (1) Current Child-Pugh patients with grade C; (2) The results of previous examinations indicate HCC patients induced by other causes: 1) Inherited metabolic liver disease (hepatolenticular degeneration, etc.); 2) Clear chronic liver disease (schistosomiasis, liver disease, etc.). HIV-Ab+; Previously diagnosed active tuberculosis; Diagnosis of other malignant tumors, non-primary hepatocellular carcinoma, etc. before admission or during hospitalization; Patients who have received allogeneic blood transfusion or cell therapy within 1 year; pregnant women.

Design outcomes

Primary

MeasureTime frame
ctDNA burden;

Countries

China

Contacts

Public ContactXiaolong Liu

Mengchao Hepatobiliary Hospital of Fujian Medical University

xiaoloong.liu@gmail.com+86 0591-83705927

Outcome results

None listed

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