Hepatocellular,HCC
Conditions
Interventions
Gold Standard:Clinical diagnosis of hepatocellular carcinoma (including but not limited to imaging, pathology, serology, etc.)
Index test:1. The product is used to evaluate the detection performance of three micrornas (miR-21, miR-125a, miR-150) in extracellular vesicles of human serum samples
2. The product is used to evaluate the AFP detection performance in serum samples
3. Evaluation of changes in test results before and after hepatectomy or ablation for hepatocellular carcinoma
4. Conduct usability and security evaluation for supporting analysis software.
Sponsors
Beijing Ditan Hospital, Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Samples that meet all the following conditions can be selected as clinical trial samples: (1) The subjects shall meet any of the following conditions: ? Population with liver’s space-occupying lesions and unknown nature(Intrahepatic nodule diameter > 2cm: MRI enhanced by multi-parameter MRI, dynamic enhanced CT, contrast-enhanced ultrasound or hepatocellular specific contrast agent Gd-EOB-DTPA showed no typical characteristics of liver cancer in the four imaging examinations. Intrahepatic nodules =2cm in diameter: up to 1 of the 4 imaging studies showed typical liver cancer features). ? Population with liver’s space-occupying lesions and initial diagnosis of primary hepatocellular carcinoma (HCC). This group of subjects should include different stages (CNLC stages I, II, III, IV). This should include HCC patients who have undergone hepatectomy or ablation therapy and need to return to the hospital for reexamination 2-3 months after surgery. ? Population with liver’s space-occupying lesions and diagnosis of liver metastases. ? Subjects diagnosed as other digestive system tumors or non-digestive system tumors, including: intrahepatic cholangiocarcinoma (ICC), Mixed hepatocellular carcinoma - Cholangiocarcinoma (cHCC-CCA), gastric cancer, colorectal cancer, esophageal cancer, lung cancer, breast cancer, etc. ?Subjects diagnosed with benign liver diseases included hepatic cysts, liver hemangiomas, adenoid tumor, viral hepatitis, fatty liver, and cirrhosis. (2) The subjects providing the sample should have clear case information, including outpatient/inpatient number, sample number, age, gender, clinical diagnosis, etc. The age of the subjects is not less than 18 years old and the gender is not limited. (3) Subjects who voluntarily participate in this clinical trial and are able to collect peripheral blood samples.
Exclusion criteria
Exclusion criteria: Subject samples with one or more of the following shall be excluded: (1) Patients with liver cancer who have received immunotherapy or targeted drug therapy within 6 months. (2) The medical information of the subjects was incomplete, and the samples did not meet the inclusion criteria (2). (3) Samples collected and stored that do not meet the requirements of evaluation reagents and comparative reagents/methods.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Micro-RNA miR-21;Micro-RNA miR-125a;Micro-RNA miR-150;AFP(alpha fetoprotein); | — |
Countries
China
Contacts
Public ContactWang Qi/Chen Jing Long/Wang Ya Jie
Beijing Ditan Hospital, Capital Medical University
Outcome results
None listed