Clinical trial NCT06559761: Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
Official title: Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatocellular Carcinoma Stage III
Keywords: Hepatocellular Carcinoma
Prognosis
Imaging
Gross classification
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
Collaborators: name: The First Hospital of Jilin University
First posted: 2024-08-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients pathologically diagnosed with hepatocellular carcinoma and underwent curative-intent hepatectomy

Brief summary: Hepatocellular carcinoma (HCC) is a highly heterogeneous malignant tumor with significant differences in invasion, proliferation ability and patient prognosis. Currently, there is a lack of non-invasive and simple indicators to predict the prognosis of HCC patients and assist clinical decision-making. The identification of HCC macroscopic or histopathological classification requires large pathological specimens obtained through surgical resection, but only about 20% of patients are eligible for surgical treatment. Moreover, most liver cancer diagnoses can be confirmed by imaging examinations without relying on pathological results. For patients who have not undergone surgical resection, the lack of histopathological information during treatment means that there is no basis for judging tumor proliferation and obtaining rich prognostic information. Therefore, evaluating the invasion and proliferation ability of HCC based on macroscopic imaging assessment has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

Ultrasound and MRI are ideal entry points as first-line imaging methods for liver cancer diagnosis. This study aims to evaluate HCC macroscopic or histopathological classification based on multimodal imaging (ultrasound, CT, MRI), thereby assessing its invasion and proliferation ability which has important implications for guiding individualized diagnosis and treatment throughout the entire process including surgical strategy guidance, local treatment selection, systemic therapy planning as well as patient follow-up and prognosis evaluation.

By analyzing macroscopic image features we aim to explore their cross-scale correlations with HCC macroscopic classification,histopathological classification,and gene molecular typing.


Eligibility criteria: Inclusion Criteria:

* According to the WHO classification, the pathological diagnosis is hepatocellular carcinoma.
* The initial treatment is curative-intent hepatectomy.
* There is no evidence of major vascular/hepatic portal invasion, extrahepatic/lymph node metastasis, or other malignant tumors.
* Age 18-80 years old.

Exclusion Criteria:

· Not meeting any one of the inclusion criteria or being unwilling/unable to follow-up.

Primary outcomes:
measure: Overall survival
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Disease-free survival
timeFrame: through study completion, an average of 1 year
measure: Imaging features
timeFrame: through study completion, an average of 1 year
measure: Quantification of immune cells of the resected liver tumour
timeFrame: through study completion, an average of 1 year
measure: mRNA sequencing data of the resected liver tumour and peritumor parenchyma
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
References: