Clinical trial NCT06623734: Liver Cancer Prognosis Investigation Study
Official title: Liver CAncer PRognosis InvEstigation Study (Liver-CARE)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Liver Neoplasms
Keywords: Primary liver cancer
Hepatocellular carcinoma
Intrahepatic cholangiocarcinoma
Prognosis
Prospective cohort study
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 5000
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 newly diagnosed with primary liver cancer

Brief summary: 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.

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.

Primary outcomes:
measure: Death
timeFrame: Up to 20 years
Secondary outcomes:
measure: Recurrence (intrahepatic and extrahepatic)
timeFrame: 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
measure: Newly Emerging Diseases
timeFrame: 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
measure: Response Evaluation
timeFrame: through study period, every 3-6 months
measure: Nutritional status
timeFrame: through study period, every 3-6 months
measure: Quality of life
timeFrame: through study period, every 3-6 months
measure: Psychological and mental status
timeFrame: through study period, every 3-6 months
measure: Cachexia assessment
timeFrame: through study period, every 3-6 months
measure: Sarcopenia
timeFrame: through study period, every 3-6 months
measure: Frailty
timeFrame: through study period, every 3-6 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Sun Yat-sen University Cancer Center
state: Guangdong
Study officials:
affiliation: Sun Yat-sen University
name: Aiping Fang, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sun Yat-sen University
name: Yanjun Zhang, MBBS, MD
role: PRINCIPAL_INVESTIGATOR
References: