Blood ctDNA monitoring for hepatocellular carcinoma and colorectal cancer that spread to the liver

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Participants will have tumor tissue sequenced to identify tumor-specific mutations and will provide serial peripheral blood samples for plasma ctDNA testing. Identified mutations will be followed using ddPCR to detect minimal residual disease (MRD) and changes over time. The study enrolls adults with resectable or transplant-planned HCC and patients with colorectal cancer limited to the liver who are eligible for liver surgery or transplant. Investigators will correlate ctDNA presence and dynamics with imaging, clinical course, and treatment type to see if ctDNA timing predicts recurrence or progression and could inform longer-term outcomes.

Why it matters

Who can join: the full rules

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

Where it's running

• Medical University of Warsaw
  Warsaw, Masovian Voivodeship, Poland Recruiting

Study contacts

• Principal investigator: Tomasz Stokłosa, Professor — tomasz.stoklosa@wum.edu.pl
• Study coordinator: Izabela Górzyńska, Associate Professor
• Email: oskar.kornasiewicz@gmail.com
• Phone: 22 599 25 45

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.