Clinical trial · Observational
Novel Molecular Spectrometric Biomarkers in Blood Plasma as an Early Diagnostic Tool in HCC
Early Diagnostics of Hepatocellular Carcinoma in Patients With Liver Cirrhosis by Novel Molecular Spectrometric Biomarkers in Blood Plasma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Due to providing valuable clinical information while being minimally invasive, blood-based testing will most likely be a prerequisite for future large-scale screening of high-risk populations. As a variety of pathological processes, including carcinogenesis, may cause changes in both the concentration and the structure and spatial arrangement of body biomolecules, the spectroscopic analysis of blood-based derivatives appears to be an appropriate tool for the early detection thereof. The differences observed in the spectral response of healthy individuals and patients may also be specific to a particular type/stage of the disease and, thus, may serve as a reliable diagnostic marker. In order to find sufficiently specific and sensitive biomarkers of early stages of degenerative and cancerous diseases, the co-applicant group at the Department of Analytical Chemistry, University of Chemistry and Technology Prague (UCT Prague), developed a unique approach for the spectroscopic analysis of blood plasma. Using the highly specialized, structure-sensitive methods of chiroptical spectroscopy (electronic circular dichroism - ECD, Raman optical activity - ROA) combined with conventional infrared (IR) and Raman spectroscopy, the first pilot studies yielded promising results with respect to the identification of spectral markers for pancreatic cancer, colon cancer and type 1 diabetes mellitus. In addition, metabolomics appears to be a very progressive approach to finding potentially suitable molecules to distinguish between healthy and cancer-affected individuals. Therefore, the investigators believes that this multimodal approach will allow for the identification of hepatocellular carcinoma (HCC). In our research, the focus will be on the identification of novel biomarkers in blood plasma that would exhibit sufficient sensitivity and specificity to detect early and potentially curable HCC stages, and that would be potentially useful for routine screening of this disease in well-defined at-risk groups.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cirrhosis, Liver | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Liver Cancer | Malignant Liver Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| blood sampling | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- label
- Group A - Hepatocellular carcinoma
- description
- Patients with with proved hepatocellular carcinoma in cirrhosis. N=100
- interventionNames
- Other: blood sampling
- label
- Group B - Cirrhosis
- description
- Cirrhotics of multiple aethiology will be sampled for spectroscopy in order to detect possible differences among cirrhotics with and without subsequent hepatocellular carcinoma. N=100
- interventionNames
- Other: blood sampling
- label
- Group C - Healthy controls
- description
- Healthy controls - healthy military personnel. N=50
- interventionNames
- Other: blood sampling
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion criteria: Group A * age 18-80 years, signed informed consent * proved liver cirrhosis based on at least one of the following criteria: histopathological finding in liver biopsy, non-invasive procedures (transient elastography (Fibroscan by Echosens, France) and / or shear-wave elastography, evidence of portal hypertension, history of cirrhosis decompensation (variceal bleeding, jaundice, hepatic encephalopathy, ascites, edema) * HCC confirmed by EASL diagnostic algorithm Group B * age 18-80 years, signed informed consent proved liver cirrhosis based on at least one of the following criteria: histopathological finding in liver biopsy, noninvasive procedures (transient elastography (Fibroscan by Echosens, France) and or shear-wave elastography), evidence of portal hypertension, history of cirrhosis decompensation (variceal bleeding, jaundice, hepatic encephalopathy, ascites, edema) * HCC excluded according to: EASL diagnostic algorithm at baseline, negative liver ultrasound (no suspicious nodule in cirrhosis) during at least 2 examinations in 6 - month intervals (e.g. 12 months after baseline) Group C * age 18-65 years, signed informed consent * approved Czech Army recruits and active military personnel after regular examinations with normal outcome (vital functions, ECG, blood count, blood biochemistry and urine tests, chest X-ray, physical examination) Exclusion criteria: * severe co-morbidities (i.e. advanced chronic heart failure, chronic renal insufficiency stage 4 and above, long-term poorly compensated diabetes mellitus with severe complications) * absence of liver cirrhosis * history of any other cancer than HCC * pregnancy * estimated patient non-compliance and/or not signing of the informed consent
References
Publications (1)
- DERIVEDHribek P, Vrtelka O, Kralova K, Klasova J, Fouskova M, Habartova L, Kubickova K, Kupsa T, Tuma T, Setnicka V, Urbanek P. Efficacy of blood plasma spectroscopy for early liver cancer diagnostics in obese patients. Ann Hepatol. 2024 Sep-Oct;29(5):101519. doi: 10.1016/j.aohep.2024.101519. Epub 2024 Jun 10. PMID 38866366