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Blood Test Monitoring Tumour DNA After Liver Surgery in Liver and Bowel Cancer

Tests a blood tumour DNA check after liver surgery in liver or bowel cancer patients.

Key facts

Who runs it
Medical University of Warsaw
Where
Warsaw, PolandSee the site
Trial code
Registry title
ctDNA Monitoring in Patients With HCC and mCRC
Status
Recruiting
People taking part
300 people, planned
Started
1 Jan 2025
Expected to end
30 Apr 2028
Type of study
Interventional, 4 groups
Treatments tested
  • Tumor Tissue Collection and NGS
  • Blood Collection for Plasma ctDNA
  • ctDNA Mutation Analysis via ddPCR
Record updated
3 June 2025

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with colorectal cancer that spread only to the liver, or with liver cancer (HCC), who are planned for liver surgery or a liver transplant.

Age
18 to 75 years
Sex
Men and women
Disease stage
Colorectal cancer spread only to the liver after the main tumour was fully removed, or liver cancer (HCC) that can or cannot be removed by surgery. Planned for liver resection or transplant.
Earlier treatment
For colorectal cancer, any type of liver surgery. Chemotherapy before surgery is allowed if it fits the planned chemotherapy after surgery. People who had radiotherapy cannot join.

Main reasons for not taking part

  • Cancer spread outside the liver seen on scans
  • Any other cancer in the past
  • Positive virus test (does not apply to people with HCC)
  • Metabolic or autoimmune disease, or long-term steroids or immune-suppressing treatment (except after a liver transplant for HCC)
  • Pregnancy

The registry criteria, word for word

Show all 17 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Patient after radiotherapy
  • Patient participating in other clinical trials of oncological and non-oncological drugs
  • metabolic and autoimmune diseases or chronic immunosuppressive treatment other than in the group of patients after liver transplantation due to HCC
  • history of other cancer
  • Chronic steroid therapy and diagnosed active autoimmune diseases
  • age under 18 and over 75
  • pregnancy
  • patients with extrahepatic metastases visible in imaging studies
  • positive virological status, excluding the group of patients with HCC
  • Patients legally incapacitated

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Poland

  • Medical University of WarsawWarsaw, PolandContact: Izabela Górzyńska, Associate ProfessorTaking people

About the trial

What the trial wants to find out

"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 treatment applied to improve long-term survival. The ctDNA test is not a widely recognized technology for assessing the progression of neoplastic disease.

Read full original descriptionShow less

Aim of the study/research hypothesis: the aim of the project is to clinically validate the value of the ctDNA test as a tool for early diagnosis of recurrence, assessment of cancer progression, the prognosis of treatment effects, and monitoring of therapy in patients with primary liver HCC or colorectal cancer metastases.

Description of the methodology: The main objective of the work will be achieved through the implementation of specific objectives: 1) Recruitment of 300 patients, including 100 patients with colorectal liver limited metastasis, 100 patients with hepatocellular carcinoma (HCC) and 100 patients in the control group who will be qualified for liver resection or transplantation, and in whom ctDNA level testing will not be tested. 2) Taking blood samples from the patients. The detection of ctDNA requires only the collection of 10 ml of the patient's blood and the collection of specimens from the tumor after resection. Blood will be collected before, one month, and 6 months after surgery during routine oncology check-ups. Tumor specimens will be taken from the backside table and sent for final histopathological examination. Control "follow-up" will take place for 18 months from the first ctDNA blood collection.

Based on the collected material, genetic analysis will be performed. In the first stage, a tumor section taken during liver resection, and DNA from the patient's blood will be analyzed the molecular (genetic) signature of the patient's tumor will be determined and several genetic changes characteristic of the change will be selected. Thereafter, the presence of the selected genetic variants will be assessed qualitatively and quantitatively in the pre-operative blood sample and all subsequent post-operative blood samples.

The investigators assume that in a blood sample taken 4 weeks after surgery, ctDNA should be undetectable or detected at a low level. In order to assess the change in the level of ctDNA in the postoperative period, a third examination will be performed - 6 months after the operation. Any level of detected ctDNA will be considered significant.

Each increase in the level of the analyzed mutations will indicate the potential progression of the disease. The results of molecular analyzes will be correlated with the assessment of imaging tests and the level of tumor markers performed as part of routine oncological control.

This is a prospective observational study with a defined study group. These are patients with colorectal cancer metastases limited to the liver, i.e. stage IV of the cancer process, or patients with hepatocellular carcinoma (HCC) qualified for radical surgery or liver transplantation. Patients in the control group (without ctDNA tests) will be treated in accordance with the best clinical knowledge and accepted international recommendations.

The statistical analysis of the results will use the SAS (Statistical Analysis System) software, considering the Kaplan-Meier method, log-rank tests, Cox proportional hazards regression, and logistic regression.

The investigators hypothesize that the use of ctDNA will enable the identification of early disease progression or will identify patients with the highest risk of recurrence. In addition, it will improve the supervision of diseases and enable possible modification of treatment in patients with stage IV colorectal cancer or patients after liver resection or transplantation for HCC. In the future, oncological prevention will consist in blood tests, which will enable early detection of even those cancers that show symptoms only at an advanced stage, which will potentially improve the effectiveness of treatment.

The 4 groups in the trial

  • Study Group - Colorectal Cancer with Liver MetastasesOther group

    Patients with metastatic colorectal cancer to the liver. Tumor tissue obtained during surgery is subjected to DNA extraction and Next-Generation Sequencing (NGS) to identify oncogenic mutations. Blood samples are collected one day before surgery, one month, and six months after surgery. Plasma is separated from blood to isolate circulating tumor DNA (ctDNA), which is then tested using droplet digital PCR (ddPCR) to detect the mutations previously identified by NGS.

    Treatment: Tumor Tissue Collection and NGS, Blood Collection for Plasma ctDNA, and ctDNA Mutation Analysis via ddPCR

  • Study Group - Hepatocellular CarcinomaOther group

    Patients with hepatocellular carcinoma. Tumor tissue collected during surgery is analyzed using NGS to identify oncogenic mutations. Blood samples are collected at the same three time points. Plasma-derived ctDNA is tested using ddPCR for the previously detected mutations.

    Treatment: Tumor Tissue Collection and NGS, Blood Collection for Plasma ctDNA, and ctDNA Mutation Analysis via ddPCR

  • Control Group - Colorectal Cancer with Liver MetastasesOther group

    Patients with metastatic colorectal cancer to the liver meeting control group criteria. Blood samples are collected one day before surgery, one month, and six months after surgery. Plasma is separated and stored, but no NGS or ddPCR analyses are performed.

    Treatment: Blood Collection for Plasma ctDNA

  • Control Group - Hepatocellular CarcinomaOther group

    Patients with hepatocellular carcinoma meeting control group criteria. Blood is collected at three predefined time points. Plasma is separated and stored. No molecular or genetic testing is conducted on these samples.

    Treatment: Blood Collection for Plasma ctDNA

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
A Prospective Randomized Trial Assessing the Impact of ctDNA Testing in Patients After Liver Resection or Transplantation Due to Metastases From Colorectal Cancer or Hepatocellular Carcinoma (HCC) on Treatment Strategies and Long-term Survival"
Plain-language title
Blood Test Monitoring Tumour DNA After Liver Surgery in Liver and Bowel CancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT07001085, who can take part
Publications
Record updated
3 June 2025