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The goal of this prospective cohort study is to evaluate the role of transient elastography (Fibroscan) in predicting the response of immunotherapy in advanced Hepatocellular carcinoma (HCC) patients.
Researchers will predict the response to 6 months of HCC immunotherapy regarding improvement of the degree of liver fibrosis, development of liver decompensation, complications, survival, and mortality.
Participants will undergo history-taking, clinical examination, laboratory investigations, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), and Fibroscan examination at baseline and follow-up after 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC patients at baseline | At baseline, patients will undergo history-taking, clinical examination, laboratory investigations, Child-Pugh classification, Model for End-stage Liver Disease (MELD) score, BCLC staging, abdominal ultrasonography, Triphasic CT abdomen with contrast or MRI (for evaluation of tumor site, size and number), and Fibroscan examination |
| |
| HCC patients 6 months post immunotherapy | All patients will be followed up after 6 months with clinic visits including laboratory testing, evaluation of treatment-related side effects, imaging studies, and fibroscan examination. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibroscan | Radiation | Liver fibrosis and steatosis can be staged using Dimensional ultrasound TE (transient elastography). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes of liver stiffness measurement (kPa) | Measuring liver stiffness (kPa) using Fibroscan before and 6 months after immunotherapy. | through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Decompensation rate | measuring liver decompensation rate after 6 months of immunotherapy | through study completion, an average of 1 year |
| Mortality rate at 6 months follow-up | assessing mortality rate after 6 months of immunotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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This prospective cohort study will be carried out on 80 patients attending to Tanta tropical medicine outpatient clinic, faculty of medicine. The start of the research will be in January 2025 to January 2026 or until collecting the cases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rania M Elkafoury, MD | Contact | +201004672358 | rania.elkafoury@med.tanta.edu.eg | |
| Nabila A Elgazzar, MD | Contact | 00201288585733 | nabilaelgazzar@med.tanta.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Nabila A Elgazzar, MD | Tropical medicine and infectious diseases Department, Faculty of Medicine, Tanta University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tanta University Hospitals | Recruiting | Tanta | Gharbyea | 31516 | Egypt |
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| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| through study completion, an average of 1 year |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |