Clinical trial · Observational
GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescence PCR Method)
Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Hepatocellular Carcinoma: a Clinical Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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: 1. How consistent are the test results of the kit with the clinical reference diagnostic criteria? 2. 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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Positive group
- description
- The positive group is composed of patients with hepatocellular carcinoma of different stages and pathological types.
- interventionNames
- Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
- label
- Negative group
- description
- 1. Patients with other digestive system malignancies (including stomach cancer, esophageal cancer, colorectal cancer, pancreatic cancer, gallbladder/duct cancer, etc.), patients with non-digestive system malignancies (including lung cancer, thyroid cancer, cervical cancer, endometrial cancer, breast cancer, prostate cancer, urothelial cancer, etc.). 2. Patients with benign liver diseases (such as cirrhosis, hepatitis, fatty liver, liver adenoma, liver cyst, etc.).
- interventionNames
- Diagnostic Test: GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescent PCR Method)
Primary outcomes (1)
- measure
- validity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Those who meet any of the following conditions can be enrolled into the hepatocellular carcinoma group： 1. 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)； 2. 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： 1. Patients with benign liver diseases (including cirrhosis, hepatitis, fatty liver, liver adenoma, liver cyst, etc.). 2. 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： 1. Patients with hepatocellular carcinoma who have received anti-tumor treatments such as radiotherapy/chemotherapy； 2. Hepatocellular carcinoma patients suffering from other malignant tumors at the same time； 3. Samples that are not kept as required or samples of hemolysis； 4. The sample size collected does not meet the testing requirements；
References
Publications (0)
Data not yet available