Hepatitis B, cirrhosis, Hepatobiliary system malignancy
Conditions
Interventions
Gold Standard:Patients with chronic hepatitis B: positive blood for hepatitis B virus surface antigen or HBV-DNA >= 10^5 copies/mL.
Patients with hepatitis B cirrhosis: positive blood for HBV surface
Index test:High-throughput polypeptide profiles, polypeptide markers, are expected to achieve diagnostic sensitivity of 95%, specificity of 100%, and accuracy of 95%
Sponsors
Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Inclusion criteria for hepatobiliary malignancy cohort ? Age =18 years old. ? Patients who have been pathologically and/or clinically diagnosed as hepatobiliary malignancies. ? Volunteer to participate in the study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity or other reasons, its guardian is required to represent the informed process and sign the informed consent. If the subject does not have the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form. (2) Interference cohort inclusion criteria ? Age =18 years old. (2) No malignant tumors of the hepatobiliary system, and no suspected malignant tumor lesions were found clinically and/or on imaging. ? meet any of the following conditions: Chronic hepatitis B (HBV chronic infection), chronic hepatitis C (HCV chronic infection), cirrhosis of any cause, alcoholic liver disease, metabolic dysfunction-associated fatty liver disease (MAFLD). ? Volunteer to participate in the study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity or other reasons, its guardian is required to represent the informed process and sign the informed consent. If the subject does not have the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form. (3) Inclusion criteria of healthy population cohort ? At least 18 years of age, without any physical discomfort. (2) No malignant tumors of the hepatobiliary system, and no suspected malignant tumor lesions were found clinically and/or on imaging. Patients without any of the following factors: chronic hepatitis B (HBV chronic infection), chronic hepatitis C (HCV chronic infection), cirrhosis of the liver from any cause, alcoholic fatty liver disease, MAFLD. ? People who are judged healthy by physical examination or clinical comprehensive judgment. ? Volunteer to participate in this study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity or other reasons, its guardian is required to represent the informed process and sign the informed consent. If the subject does not have the ability to read the informed consent form (such as illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.
Exclusion criteria
Exclusion criteria: ? Pregnancy or lactation period. ? There is a severe bleeding tendency, or a major trauma that requires blood transfusion treatment has occurred within a week. Have participated in a clinical intervention study within the past 30 days (e.g., have taken an experimental drug). Have undergone surgery, radiation, chemotherapy, targeted therapy, or other relevant tumor interventions in the past 30 days. ? Also suffering from other malignant tumors. ? Other reasons that the researchers found unsuitable for inclusion in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum peptides profile;Accuracy;Sensitivity;Specificity; | — |
Secondary
| Measure | Time frame |
|---|---|
| Positive predicative value; | — |
Countries
China
Contacts
Public ContactLiang Xiao
Sir Run-Run Shaw Hospital, Zhejiang University School of Medicine
Outcome results
None listed