MedTrace Logo

Vascular Invasion Signatures in cfDNA Support Re-staging of Liver Cancer

NCT05540925 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 286

Last updated 2022-09-19

No results posted yet for this study

Summary

Tumor staging system based on clinicopathological charactertics has been used to guide treatment decisions. However, therapeutic outcomes of "early-stage" hepatocellular carcinoma (HCC) differs significantly, which strongly suggests the requirement for a re-staging of early HCC to inform treatment selection more precisely. Microvascular invasion (MVI) reflects malignant biological characteristics of early HCC, and has a potential role of guiding treatment selection. As such, the objective of this study is to investigate preoperative MVI prediction based on MVI-related genomic signatures of cell-free circulating tumor DNA (ctDNA) to establish a re-staging of early HCC. The investigators have detected 37 mutant genes associated with MVI in HCC tumor tissues. In this study, the investigators will design a gene panel based on these mutant genes to perform targeted gene sequencing on preoperatively collected ctDNA to identify genomic signatures associated with MVI. A nomogram to predict MVI before treatment will be generated by incorporating these genomic signatures. Based on a calculated optimal cut-off value of the nomogram, early HCC patients can be re-staged into subpopulations based on the nomogram-predicted risks of MVI. This study will develop a re-staging system of early HCC based on tumor biological charactertics, which is expected to accurately and individually guide treatment decisions and improve long-term survival outcomes.

Conditions

  • Carcinoma, Hepatocellular
  • Hepatocellular Cancer
  • Liver Cancer

Interventions

PROCEDURE

Liver resection

All patients underwent curative-intent resection for early-stage HCC (a solitary tumor nodule≤5 cm, or multiple nodules≤3, each≤3 cm). We did not take any other intervention. We retrospectively analyzed the prognostic performance of patients with wide (≥1cm) or narrow (\<1cm) resection margin in different groups.

Sponsors & Collaborators

  • Eastern Hepatobiliary Surgery Hospital

    lead OTHER

Principal Investigators

  • Feng Shen, MD, PhD · Eastern Hepatobiliary Surgery Hospital, Naval Medical University

Eligibility

Min Age
25 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-01
Primary Completion
2022-06-01
Completion
2022-09-01

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05540925 on ClinicalTrials.gov