Using circulating tumor DNA to predict return of liver cancer after curative treatment
Prediction of Hepatocellular Carcinoma Recurrence After Curative Treatment by Monitoring Circulating Tumor DNA: a Prospective Cohort Study
This trial will test whether a simple blood test for circulating tumor DNA (ctDNA) can help predict if hepatocellular carcinoma will come back in people who've had curative surgery or radiofrequency ablation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Rouen Academic / other |
| Locations | 1 site (Rouen) |
| Trial ID | NCT05375370 on ClinicalTrials.gov |
What this trial studies
This single-center pilot will measure ctDNA in blood drawn before and after curative resection or radiofrequency ablation, then again at three and six months of follow-up. The study enrolls adults with hepatocellular carcinoma diagnosed by accepted imaging criteria or histology who receive treatment at the coordinating hospital. Researchers will compare ctDNA detection and levels to clinical and pathological features and subsequent tumor recurrence. The aim is to see if ctDNA can identify microscopic residual disease and predict early relapse to improve post-treatment surveillance.
Who should consider this trial
Good fit: Adults (≥18) with hepatocellular carcinoma treated with curative liver resection or radiofrequency ablation who can attend follow-up at Charles Nicolle University Hospital in Rouen are ideal candidates.
Not a fit: Patients with another active cancer, contraindications to the planned curative treatment, or who cannot complete follow-up at the Rouen center are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, ctDNA testing could allow earlier detection of recurrence and help clinicians tailor closer monitoring or additional therapy for patients at higher risk.
How similar studies have performed: Prior studies in various cancers and emerging data in HCC suggest ctDNA can detect subclinical disease and correlate with recurrence risk, but this approach is not yet established as standard care for HCC.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥ 18 years 2. HCC diagnosed on consensus radiological criteria in cirrhotic patients (EASL-EORTC 2012): helical CT or MRI with triple arterial, portal and late acquisition. The diagnosis is based on the presence of hypervascularization at the early arterial time (wash-in) with wash-out (hypodensity or hypointensity compared to non-tumor liver parenchyma) at the portal phase or late phase compared to non-tumor parenchyma. 3. HCC diagnosed histologically in the absence of a diagnosis on imaging (see IC n°2 above) 4. Patient operated on for liver resection or radiofrequency destruction 5. Treatment decision validated by the digestive oncology PCR 6. Patient having read and understood the information letter and signed the non-opposition form 7. Patient follow-up at the Charles Nicolle University Hospital in Rouen Exclusion Criteria: 1. Other active cancer or hematological malignancy 2. Contra-indication to surgery 3. Patient not affiliated to the social security system 4. Pregnant woman or parturient or breastfeeding 5. Person under court protection, sub guardianship or curatorship
Where this trial is running
Rouen
- Chu Rouen — Rouen, France (Recruiting)
Study contacts
- Principal investigator: Edouard ROUSSEL, MD — University Hospital, Rouen
- Study coordinator: Edouard ROUSSEL, MD
- Email: edouard.roussel@chu-rouen.fr
- Phone: +3323288
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.