cfDNA Methylation for Liver Cancer Recurrence Detection

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWuhan Ammunition Life-tech Co., Ltd

About this trial

Through follow-up testing of patients with primary liver cancer who underwent hepatectomy, liver transplantation, ablation therapy, or transarterial chemoembolization (TACE), a blinded comparative trial was conducted at each monitoring site. This trial evaluated the combined methylation detection kit for GNB4 and Riplet genes (fluorescent PCR method) against the clinical reference standard (defined as the physician's comprehensive diagnosis based on clinical guidelines and other criteria). The study evaluated the clinical performance of the assay in diagnosing primary liver cancer recurrence and validated the clinical efficacy of methylation detection kits for monitoring recurrence after primary liver cancer treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary liver cancer

Disqualifiers

Concurrent other malignant tumors;

Ineligible for hepatectomy, liver transplantation, ablation, or TACE therapy;

Negative methylation status prior to treatment.

Trial population

This study investigates patients with primary liver cancer, encompassing three types: hepatocellular carcinoma, intrahepatic cholangiocarcinoma, and mixed liver cancer.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • plasma GNB4 and Riplet genes methylation detection

    Diagnostic test

    Liver cancer patients undergo methylation testing at different follow-up time points after treatment

Treatment groups

500 Participants
are divided into 1 treatment group
Group A: Primary liver cancer patients1 intervention

Trial outcomes

Primary outcomes

1

sensitivity

Time frame
Through study completion, an average of 1 year
2

specificity

Time frame
Through study completion, an average of 1 year

Secondary outcomes

Other outcomes

Sponsors and contacts

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