hepatocellular cancer
Conditions
Interventions
Index test:Proteins in Peripheral Blood
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1.Voluntarily sign informed consent. 2.Male or female, age equal to or greater than 18 years old, less than 75 years old; 3.Cancer group: patients with liver cancer who were diagnosed or suspected for the first time within 42 days before blood collection; The subject did not undergo any local or systemic anti-tumor therapy before blood collection, including (but not limited to) tumor surgical treatment for any purpose, local or systemic chemoradiotherapy, targeted therapy (including anti-angiogenic drugs), immunotherapy, cancer vaccine and hormone therapy, etc. 4.Benign lesion group: Subjects with liver benign lesions diagnosed by tissue pathology or suspected liver benign lesions within 90 days prior to blood collection, or highly suspected liver benign lesions based on imaging evaluation or other routine clinical diagnosis. Subjects have not undergone any curative treatment specifically targeting the benign lesion prior to blood collection. 5.Healthy population group: no cancer-related clinical symptoms within 30 days prior to blood collection. No clinical signs of any discomfort within 30 days prior to blood collection. The subjects underwent conventional abdominal ultrasound or abdominal non-contrast CT: the scanning range was normal for liver, gallbladder, pancreas, and spleen (no clinically significant pathological findings). The subjects were tested for HBV in two pairs and halves, hepatitis B surface antigen (HBsAg), e antigen (HBeAg), hepatitis B surface antibody (Anti-HBs), core antibody (Anti-HBc), e antibody (Anti-HBe), HCV antibody in an informed and consenting manner, and the results were normal (hepatitis B surface antigen and HCV antibody were negative).
Exclusion criteria
Exclusion criteria: 1.Female subjects who are pregnant or breastfeeding. 2.Previous organ transplantation or non-autologous bone marrow or stem cell transplantation. 3.Received drugs with anti-tumor effects for other diseases within 30 days before blood collection, such as drugs used for the treatment of immunorheumatic diseases such as methotrexate, cyclophosphamide, thiazoprine, chlorambucil, etc., drugs for the treatment of breast diseases, such as tamoxifen, etc. 4.History of previous malignant tumors. 5.Having other malignant tumors or multiple primary tumors at the same time. 6.Received a blood transfusion within 7 days prior to blood collection; 7.Cancer group: History of malignant tumor diseases in the past. Also diagnosed with other malignant tumors or multiple primary tumors. Within 42 days after blood collection, the subject still cannot be confirmed as having cancer through tissue pathology reports or imaging, or the tissue pathology report indicates benign, or the nature of the lesion cannot be determined. 8.Benign lesion group: history of previous malignant neoplastic disease. Confirmed diagnosis of malignancy or precancerous lesions. Patients with benign lesions who cannot be diagnosed by imaging, endoscopy, or histopathology within 42 days after blood collection, or whose diagnosis is unknown or insufficient to judge the nature of the lesions. 9.Healthy population group: subjects who have received or are receiving curative treatment for cancer within 3 years before blood sampling (the end of the last curative treatment is used as the time, and adjuvant hormone therapy is not counted as curative therapy.) Unexplained weight loss, defined as a loss of >7.5 kg in the past year. Previous major illness of the following, whether currently well controlled: chronic obstructive pulmonary disease, interstitial lung disease such as pulmonary fibrosis, viral hepatitis, post-hepatitis cirrhosis, inflammatory bowel disease such as Crohn's disease or ulcerative colitis. Previous colonoscopy and findings of intestinal adenoma or polyps. Within 30 days before blood collection, there were symptoms such as changes in bowel habits, abnormal stool shape, and blood in the stool. Presence of poorly controlled hypertension (160 mmHg per SBP= and/or DBP=100 mmHg) (initiation or adjustment of antihypertensive medications prior to study entry is permitted). Poorly controlled heart disease such as myocardial infarction, severe/unstable angina, congestive heart failure, etc. Current presence of a bleeding disorder, such as immune thrombocytopenic purpura or hemophilia. Major surgery (e.g., intrathoracic, intra-abdominal, or pelvic) within 24 weeks prior to blood collection. Have had an infectious disease requiring clinical intervention within 24 weeks prior to blood collection. Presence of autoimmune diseases such as rheumatoid arthritis, ankylosing spondylitis, systemic lupus erythematosus, psoriasis, etc. The subject is judged by the investigator to have other clinically significant and/or poorly controlled concomitant diseases that are not suitable for participation in this clinical study, such as (but not limited to): active infection or poorly controlled infection including tuberculosis, human immunodeficiency virus (HIV) infection, etc. (testing for HIV is not mandatory).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proteins in Peripheral Blood; | — |
Secondary
| Measure | Time frame |
|---|---|
| Diagnostic model specificity, sensitivity and AUC; | — |
Countries
China
Contacts
Public ContactWeilin Wang
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed