A Prospective Randomized Trial Assessing the Impact of ctDNA Testing in Patients After Liver Resection or Transplantation for Colorectal Cancer Metastases or Hepatocellular Carcinoma on Treatment and Survival

What this Trial Is About

Researchers are studying the use of a blood test called circulating tumor DNA (ctDNA) to monitor liver cancer and colorectal cancer that has spread to the liver. This prospective observational study aims to validate whether ctDNA testing can help detect cancer recurrence early, track disease progression, predict treatment outcomes, and monitor therapy in patients undergoing liver surgery or transplantation. The study involves patients with colorectal liver metastases, hepatocellular carcinoma (HCC), and a control group without ctDNA testing. Participants will be divided into groups based on their cancer type and whether they receive ctDNA testing. Tumor tissue samples collected during surgery will undergo genetic analysis using Next-Generation Sequencing (NGS) to identify mutations. Blood samples will be collected one day before surgery, one month after, and six months after surgery. Plasma will be used to isolate ctDNA, which is analyzed with droplet digital PCR (ddPCR) to detect mutations. Control group patients will have blood samples collected but without molecular testing. During the study, patients will have physical exams, quality of life assessments, laboratory tests, and imaging as part of regular oncological follow-up. Researchers will compare ctDNA levels with imaging and tumor marker results to assess cancer progression and recurrence. The main outcomes include evaluating ctDNA levels and mutation status before and after surgery up to six months, with additional quality of life and imaging comparisons over four years. The study will monitor patients for up to 18 months after the first ctDNA blood collection to understand the clinical value of ctDNA monitoring.

ctDNA Monitoring in Patients With HCC and mCRC