liver cancer
Conditions
Interventions
HCC Cohort(Metastatic Subgroup vs Non?Metastatic Subgroup):None
Other Solid Tumor Group (Lung Cancer):None
Non-Solid Tumor Group (Leukemia):None
Sponsors
Jiangjin Central Hospital of Chongqing
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Hepatocellular Carcinoma (HCC) Cohort(Metastatic Subgroup vs Non-Metastatic Subgroup): Pathologically or cytologically confirmed diagnosis of primary HCC according to the Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2024 Edition); No prior antitumor therapy of any kind prior to blood collection, including surgical resection, ablation, transarterial chemoembolization (TACE), radiotherapy, systemic chemotherapy, or targeted/immunotherapy (i.e., treatment-naïve patients). Metastatic Subgroup: Presence of HCC metastasis confirmed by imaging (contrast-enhanced CT/MRI, PET-CT, etc.) and/or pathology, based on the BCLC staging system and the 8th edition of the AJCC/UICC TNM staging system. Non-Metastatic Subgroup: No evidence of HCC metastasis on comprehensive imaging assessment. 2.Healthy Control Group: Enrolled from individuals who underwent routine health check-ups at the health examination center of our hospital during the same period, with remaining blood samples available for collection. No evidence of any malignancy was identified based on comprehensive assessment, including systematic medical history taking, physical examination, laboratory tests (complete blood count, liver and renal function tests, tumor markers such as AFP, CEA, CA19-9, etc.), and imaging studies (abdominal ultrasound, chest X-ray/CT, etc.). Negative for HBsAg and anti-HCV, with all liver function parameters within normal reference ranges. No family history of hepatocellular carcinoma (in first-degree relatives) or history of other hereditary tumor syndromes. 3.Other Solid Tumor Group (Lung Cancer): Pathologically confirmed as a solid malignant tumor other than hepatocellular carcinoma, with the lung unequivocally identified as the primary site, according to the Chinese Medical Association Guidelines for Clinical Diagnosis and Treatment of Lung Cancer (2023 Edition); Newly diagnosed and treatment-naïve, with no prior antitumor therapy of any kind (surgery, chemotherapy, radiotherapy, targeted therapy, immunotherapy, etc.) before blood collection. 4.Non-Solid Tumor Group (Leukemia): Diagnosed according to the Chinese Guidelines for the Diagnosis and Treatment of Adult Acute Myeloid Leukemia (2021) and the Chinese Guidelines for the Diagnosis and Treatment of Chronic Lymphocytic Leukemia, with definitive diagnosis of acute leukemia (AML, ALL) or chronic leukemia (CML, CLL) established by bone marrow aspiration/biopsy, flow cytometry, cytogenetics, and molecular biology assays; Newly diagnosed and treatment-naïve, with no prior chemotherapy, radiotherapy, targeted therapy, immunotherapy, or hematopoietic stem cell transplantation before blood collection (i.e., untreated at the time of phlebotomy); Peripheral blood contains variable numbers of leukemic cells depending on the disease characteristics, but the samples still meet the general criteria for residual blood samples.
Exclusion criteria
Exclusion criteria: 1.HCC Cohort(Metastatic Subgroup vs Non-Metastatic Subgroup):Combined hepatocellular-cholangiocarcinoma (cHCC-CCA) or unclear pathological type; Recurrence after prior curative or palliative treatment for HCC; Concurrent malignant tumors of other histological origins within the past 5 years (except for adequately treated cervical carcinoma in situ and basal cell carcinoma of the skin, etc.); Child-Pugh class C liver function, or concomitant end-stage liver disease such as severe hepatic encephalopathy or refractory ascites. 2.Healthy Control Group: Persistent abnormal elevation of any tumor markers, confirmed by repeat testing to be still above the normal range and without exclusion of malignancy; Presence of indeterminate space-occupying lesions (e.g., unclassified pulmonary nodules =8 mm, hepatic space-occupying lesions other than liver cysts, thyroid nodules with TI-RADS category 4 or higher, etc.); Diagnosis of cirrhosis (of any etiology), chronic active hepatitis, or liver stiffness measurement indicating fibrosis stage =F2; Acute infection, febrile illness, or active inflammatory disease (e.g., pneumonia, enteritis, etc.) within the past 4 weeks; History of solid tumor or hematological malignancy (including clinically cured cases); History of long-term chemotherapy, radiotherapy, or immunosuppressant use. 3.Other Solid Tumor Group (Lung Cancer): Presence of indeterminate intrahepatic space-occupying lesions that cannot be ruled out as primary HCC by imaging, or pathological findings suggestive of hepatoid adenocarcinoma or other special types; History of HCC, or diagnosis of two or more malignant solid tumors (multiple primary cancers), unless the other tumor has been cured with no recurrence for more than 5 years; Emergency surgery or interventional procedures performed due to acute conditions such as obstruction, perforation, or massive hemorrhage prior to blood collection, which may have induced a severe stress state. 4.Non-Solid Tumor Group (Leukemia): Concurrent pathologically confirmed solid malignant tumor (double primary cancer); Hematological abnormalities caused by bone marrow metastasis of solid tumors, with the primary diagnosis being a solid tumor; Premalignant conditions that do not meet the diagnostic criteria for malignancy, such as monoclonal gammopathy of undetermined significance (MGUS) or solitary plasmacytoma (without meeting criteria for myeloma); Any prior anti-hematological malignancy therapy before blood collection, including cytoreductive agents such as hydroxyurea, or investigational CAR-T/antibody therapies, etc.; Severe disseminated intravascular coagulation (DIC), hyperleukocytic leukostasis, or other conditions requiring emergency intervention, where urgent treatment may have been administered at the time of blood collection.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| G protein-coupled receptor 37 like 1(GPR37L1);Carbohydrate sulfotransferase 6(CHST6);Polo-like kinase 1(PLK1);Chaperonin containing TCP1 subunit 8(CCT8); | — |
Secondary
| Measure | Time frame |
|---|---|
| Model performance: specificity, AUC, etc.; | — |
Countries
China
Contacts
Public ContactHe Xin
Jiangjin Central Hospital of Chongqing
Outcome results
None listed