Status:
RECRUITING
ctDNA Monitoring in Patients With HCC and mCRC
Lead Sponsor:
Medical University of Warsaw
Collaborating Sponsors:
Medical Research Agency, Poland
Conditions:
HCC - Hepatocellular Carcinoma
Colorectal Cancer Metastatic
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
"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...
Detailed Description
Health problem Hepatocellular carcinoma (HCC) is the most common primary malignant tumor of the liver. It is estimated that it accounts for 80-90% all cases of liver cancer. Liver cancer is one of the...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2028
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07001085
Start Date
January 1 2025
End Date
April 30 2028
Last Update
June 3 2025
Active Locations (1)
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1
Medical University of Warsaw
Warsaw, Masovian Voivodeship, Poland, 02-091