Liver Cancer Prognosis Investigation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Liver Neoplasms. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Liver CAncer PRognosis InvEstigation Study (Liver-CARE)
Overview
This prospective cohort study is designed to explore the role of environmental, clinical, and genetic risk factors in the progression and prognosis of primary liver cancer (PLC). We will recruit 5000 patients with newly diagnosed, previously untreated PLC. The eligible patients will be asked to complete a baseline survey at the time of initial admission and be followed up every 3 to 6 months after discharge.
Detailed description
Primary liver cancer (PLC) is highly malignant and is particularly prevalent in China. Multiple factors are involved in the development and progression of PLC. Several large-scale, prospective cohort studies have been established to identify environmental and genetic risk factors for the development of PLC in the general population. However, few cohort studies have focused on determining risk factors beyond clinical prognostic factors for the progression of PLC in patients with PLC. Therefore, we will conduct a prospective cohort study to examine the role of environmental, clinical, and genetic risk factors in the progression and prognosis of PLC. We plan to recruit 5000 patients with newly diagnosed, previously untreated PLC. A baseline survey will be conducted at the time of initial admission, with follow-up at 3 and 6 months after discharge for all patients and thereafter every 3 months for patients treated with interventional therapy and every 6 months for patients receiving surgery and other therapies. We will collect information on patients' demographics characteristics, clinical diagnosis and treatment, lifestyle, nutritional status, psychological and mental status, quality of life, anthropometric data, body composition, routine laboratory tests and examinations, and disease progression through structured questionnaires, physical examinations, and medical record reviews. Deaths will be ascertained through medical records, death certificates, and next-of-kin. Additionally, we will collect blood, urine, stool, and liver tissue samples.
Primary outcome measures
- Death [Time frame: Up to 20 years]
Secondary outcome measures (9)
- Recurrence (intrahepatic and extrahepatic) [Time frame: From date of diagnosis until the date of cancer recurrence or date of death from any cause, whichever came first, assessed up to 20 years]
- Newly Emerging Diseases [Time frame: From date of diagnosis until the date of newly emerging diseases or date of death from any cause, whichever came first, assessed up to 20 years]
- Response Evaluation [Time frame: through study period, every 3-6 months]
- Nutritional status [Time frame: through study period, every 3-6 months]
- Quality of life [Time frame: through study period, every 3-6 months]
- Psychological and mental status [Time frame: through study period, every 3-6 months]
- Cachexia assessment [Time frame: through study period, every 3-6 months]
- Sarcopenia [Time frame: through study period, every 3-6 months]
- Frailty [Time frame: through study period, every 3-6 months]
Eligibility criteria
Inclusion criteria
- Age 18-80 years,
- Diagnosed with primary liver cancer (ICD-10: C22) (Referring to the diagnostic criteria in the "Primary Liver Cancer Diagnosis and Treatment Guidelines (2024 Edition)" and the "2024 CSCO Guidelines for the Diagnosis and Treatment of Biliary Malignancies),
- Have not received any anti-tumor treatment (e.g., surgery, ablation, interventional therapy, radiotherapy, chemotherapy, targeted therapy, immunotherapy, etc),
- Signed informed consent.
Exclusion criteria
- Have a history of other malignant tumors,
- Have a history of other serious chronic diseases (e.g., heart failure, liver failure, kidney failure, etc.),
- Expected survival time is no more than 3 months,
- Severe physical or mental disability.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Sun Yat-sen University Cancer Center — Guangzhou
Identifiers
NCT: NCT06623734 · SYSU SPH MEC 2024-101