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ctDNA Monitoring in Patients With HCC and mCRC

RecruitingNAAges 18 Years - 75 YearsAllMedical University of Warsaw
NCT07001085 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

"Liquid biopsy" is a collective term that refers to the analysis of cancer-derived biomarkers isolated from the biological fluids of cancer patients. The analysis of these blood components can be used for early cancer detection, staging, prognosis, drug resistance monitoring, and minimal residual disease (MRD) monitoring. The "liquid biopsy" is based on the fact that cancer cells release their DNA into the bloodstream, known as ctDNA (circulating tumor DNA). A sample of the patient's peripheral blood is sufficient to test ctDNA. There have been many studies in the literature on the usefulness of liquid biopsy in the treatment of various malignancies, such as breast cancer, prostate cancer, and colorectal cancer. However, this has been a lack of prospectively obtained data analyzing the impact on the ctDNA assessment of the progression and recurrence of the primary disease or the type of

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📋 Eligibility rules (as published)
Inclusion Criteria: * age 18-75 years of both sexes; * patients with synchronous or metachronous metastases of colorectal cancer limited to the liver after complete removal of the primary lesion from the intestine qualified for liver resection or transplantation; * or patients with resectable or unresectable HCC scheduled for liver resection or transplantation * no history of other cancers; * negative virological status in the case of mCRC; * In the case of mCRC - patient after any type of liver surgery (staged, ALPPS, multi-site resection) * Patient with or without neoadjuvant chemotherapy compatible with established adjuvant therapy Exclusion Criteria: * age under 18 and over 75; * pregnancy * patients with extrahepatic metastases visible in imaging studies; * metabolic and autoimmune diseases or chronic immunosuppressive treatment other than in the group of patients after liver transplantation due to HCC; * positive virological status, excluding the group of patients with HCC; * history of other cancer; * Chronic steroid therapy and diagnosed active autoimmune diseases * Patient after radiotherapy * Patient participating in other clinical trials of oncological and non-oncological drugs * Patients legally incapacitated
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What it tests

  • Tumor Tissue Collection and NGS
  • Blood Collection for Plasma ctDNA
  • ctDNA Mutation Analysis via ddPCR
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Where

1 site
Medical University of Warsaw
Warsaw, Poland
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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