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Not Yet Recruiting NCT05668793

GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescence PCR Method)

Conditions: Hepatocellular Carcinoma

Sex: All
Ages: 18 Years – N/A
Enrollment: 1000
Sponsor: Wuhan Ammunition Life-tech Co., Ltd

Summary

The goal of this observational study is to test the clinical efficacy of "GNB4 and Riplet gene methylation combined detection kit (fluorescence PCR method)"in hepatocellular carcinoma auxiliary diagnosis. The main questions it aims to answer are:How consistent are the test results of the kit with the clinical reference diagnostic criteria?Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting GNB4 and Riplet gene methylation.Each participant is required to provide no less than 10 ml of blood to complete the kit test.

Eligibility Criteria

Inclusion Criteria:Those who meet any of the following conditions can be enrolled into the hepatocellular carcinoma group:Patients who have suspected placeholder lesions in the liver area after existing examinations and plan to undergo multi-parameter MRI, CT dynamic enhancement scans, ultrasound imaging or enhanced magnetic resonance scans with the hepatocyte-specific contrast agent disodium gadolinium cerate (Gd-EOB-DTPA);Patients who are highly suspected of liver cancer diagnosed by multi-parameter MRI, CT dynamic enhancement scan, ultrasound contrast, liver cell-specific contrast agent disodium gadolinium cerate (Gd-EOB-DTPA) enhanced magnetic resonance scan or puncture biopsy, before treatment and surgery;Those who meet any of the following conditions can be enrolled into the negative group:Patients with benign liver diseases (including cirrhosis, hepatitis, fatty liver, liver adenoma, liver cyst, etc.).Untreated patients with other digestive system tumors (including stomach cancer, colorectal cancer, esophageal cancer, pancreatic cancer, gallbladder/duct cancer, etc.) and patients with non-digestive system tumors (including lung cancer, thyroid cancer, cervical cancer, endometrial cancer, breast cancer, prostate cancer, urothelial cancer, etc.).Exclusion Criteria:Those who meet any of the following conditions should be excluded:Patients with hepatocellular carcinoma who have received anti-tumor treatments such as radiotherapy/chemotherapy;Hepatocellular carcinoma patients suffering from other malignant tumors at the same time;Samples that are not kept as required or samples of hemolysis;The sample size collected does not meet the testing requirements;

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05668793). StuddyBuddy aggregates publicly available trial information.