Image Driven Hepatocellular Carcinoma Invasiveness Evaluation Research
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2023
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2023
CompletedFirst Submitted
Initial submission to the registry
August 6, 2024
CompletedFirst Posted
Study publicly available on registry
August 19, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
August 19, 2024
August 1, 2024
6.4 years
August 6, 2024
August 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
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 Outcomes (4)
Disease-free survival
through study completion, an average of 1 year
Imaging features
through study completion, an average of 1 year
Quantification of immune cells of the resected liver tumour
through study completion, an average of 1 year
mRNA sequencing data of the resected liver tumour and peritumor parenchyma
through study completion, an average of 1 year
Study Arms (4)
TYPE I
Gross classification of resected specimen: single nodule with distinct margin, usually round with complete tumour envelope
TYPE II
Gross classification of resected specimen: single nodule with extranodular growth, no more than three extranodular points
TYPE III
Gross classification of resected specimen: a unifocal lesion composed of confluent multiple nodules, distinct boundaries among the nodules
TYPE IV
Gross classification of resected specimen: infiltrative nodule, with poor demarcated boundary and especially multiple extranodular points
Interventions
According to guideline recommended procedure of hepatectomy
Eligibility Criteria
Patients pathologically diagnosed with hepatocellular carcinoma and underwent curative-intent hepatectomy
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Biospecimen
Resected tumor specimen will be used for histological assessment and DNA/mRNA sequencing
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 6, 2024
First Posted
August 19, 2024
Study Start
January 1, 2023
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
December 31, 2029
Last Updated
August 19, 2024
Record last verified: 2024-08