- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06559761
Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chuan Pang
- Phone Number: 18910527022
- Email: pcpang117@163.com
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100853
- Recruiting
- Chinese PLA General Hospital
-
Contact:
- Ping Liang, Doctor
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TYPE I
Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope
|
According to guideline recommended procedure of hepatectomy
|
|
TYPE II
Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points
|
According to guideline recommended procedure of hepatectomy
|
|
TYPE III
Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules
|
According to guideline recommended procedure of hepatectomy
|
|
TYPE IV
Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points
|
According to guideline recommended procedure of hepatectomy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival
Time Frame: through study completion, an average of 1 year
|
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
|
through study completion, an average of 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease-free survival
Time Frame: through study completion, an average of 1 year
|
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier
|
through study completion, an average of 1 year
|
|
Imaging features
Time Frame: through study completion, an average of 1 year
|
MRI or ultrasound Imaging features of the four types
|
through study completion, an average of 1 year
|
|
Quantification of immune cells of the resected liver tumour
Time Frame: through study completion, an average of 1 year
|
Quantification of immune cells of the resected liver tumour using HE staining and immunohistological staining to assess molecular marker and cell infiltration in tumor and liver parenchyma
|
through study completion, an average of 1 year
|
|
mRNA sequencing data of the resected liver tumour and peritumor parenchyma
Time Frame: through study completion, an average of 1 year
|
mRNA sequencing data of the resected liver tumour and peritumor parenchyma specimen to assess the gene enrichment
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- S2024-423
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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