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Gene Methylation Detection Kit for Human Liver Cancer (Real-Time PCR)

Clinical Trial of Liver Cancer Gene Methylation Detection Kit (PCR Fluorescent Probe Method)

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400092883
Enrollment
Unknown
Registered
2024-11-25
Start date
2023-12-05
Completion date
Unknown
Last updated
2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver cancer

Interventions

Gold Standard:Ultrasound, CT and magnetic resonance imaging
AFP testing.
Index test:Qualitative detection of RNF135 gene PAX5 gene and CHFR gene methylation in human plasma.

Sponsors

The First Affiliated Hospital of the Air Force Medical University of the Chinese People's Liberation Army
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) The sample information is complete, including the sample medical case number, hospital number or outpatient registration number, gender, age, clinical diagnostic information, etc.; 2) The volume of peripheral blood is not less than 5ml (the size of the plasma is not less than 2.1ml). The blood samples were visually observed, and no turbidity or insoluble matter was visible to the naked eye. 3) The subjects signed an informed consent. 4) In addition to meeting the above three requirements, it is necessary to meet at least one of the following conditions before entering the group: a. People who are preparing to do liver imaging examinations with related epidemiological backgrounds, such as HBV or HCV infection, excessive drinking, non -alcoholic fatty hepatitis, other reasons, liver cirrhosis (LC), benign liver disease (BHL) ,and there are people with the history of liver cancer family; as well as people with the symptoms of the right upper abdomen, the symptoms of digestive tract such as abdominal distension, loss of appetite, nausea, vomiting, diarrhea, etc., the upper abdomen block, fever, fatigue and weight loss and other clinical manifestations; b. have liver imaging examinations and people with clear diagnosis. Among them, people who confirmed primary liver cancer need to have no history of chemotherapy or liver cancer surgery; c. Gastric cancer, bowel cancer, and esophageal cancer interfere with the crowd; d. A subject with peripheral blood volume of the peripheral blood of no less than 10ml (plasma volume is not less than 4.2 mL) (at the same time, test testing agent testing and first -generation sequencing); ? Patients with liver cancer and the same subjects before surgery and surgery or ablation.

Exclusion criteria

Exclusion criteria: 1) Pregnant women or lactating subjects; 2) Subjects with a history of liver organ transplantation; 3) Subjects clinically diagnosed with cancer liver metastasis; 4) Hemolyzed samples; 5) Insufficient samples to complete testing; 6) Samples that were not collected and stored in accordance with the [Sample Collection Requirements]; 7) Incomplete sample information (including unique identification codes such as sample hospitalization record number or outpatient registration number, gender, age, clinical diagnosis information, etc.); 8) Any other situation where the researcher deems it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
sensitivity;Specificity;Kappa value;

Secondary

MeasureTime frame
positive agreement rate;negative agreement rate;

Countries

China

Contacts

Public ContactTao Kaishan

the First Affiliated Hospital of the Air Force Medical University

zhu.zhenyu@biochainbj.com+86 10 6790 2809

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026