Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT06623734

Liver Cancer Prognosis Investigation Study

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Liver Neoplasms Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Liver Diseases Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Death

    Time frame: Up to 20 years

    The primary endpoint of this study is all-cause mortality and liver caner-specific mortality. The exact death time and the cause of death of each participant will be checked in the government medical records system.

Secondary outcomes

  1. 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

    Time of recurrence will be obtained by telephone interview or medical treatment records

  2. 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

    Time of newly emerging diseases will be obtained by telephone interview or medical treatment records

  3. Response Evaluation

    Time frame: through study period, every 3-6 months

    For patients undergoing surgical treatment, assess whether there is recurrence. For patients receiving ablation therapy, evaluate whether the tumor is completely ablated. For patients undergoing interventional therapy and radiotherapy, use the modified Response Evaluation Criteria in Solid Tumors (mRECIST) for hepatocellular carcinoma to evaluate efficacy. Use the RECIST 1.1 criteria for efficacy evaluation for patients undergoing systemic anticancer treatment. For patients receiving anti-angiogenic molecular targeted therapy, use the mRECIST criteria in combination. For patients receiving immuno-checkpoint inhibitor therapy, use the iRECIST criteria. Short-term efficacy evaluation indicators include the objective response rate (ORR), progression-free survival (PFS), disease-free survival (DFS), etc.

  4. Nutritional status

    Time frame: through study period, every 3-6 months

    To assess the nutritional risk, the patient will be screened by Nutrition Risk Screening 2002 (NRS-2002), patient-generated subjective global assessment (PG-SGA), the global leadership initiative on malnutrition (GLIM).

  5. Quality of life

    Time frame: through study period, every 3-6 months

    The assessment is based on the European Organization for Research and Treatment of Cancer (EORTC) quality of life core questionnaire QLQ-C30 for all cancer patients, the specific quality of life subscale QLQ-HCC18 for patients with liver cancer or QLQ-BIL21 for patients with intrahepatic cholangiocarcinoma.

  6. Psychological and mental status

    Time frame: through study period, every 3-6 months

    Anxiety and depression are evaluated using the Generalized Anxiety Disorder 7-item scale (GAD-7) and Patient Health Questionnaire 9-item Depression Scale (PHQ-9), recommended by the American Society of Clinical Oncology (ASCO) Adult Cancer Survivor Anxiety and Depression Management Guidelines.

  7. Cachexia assessment

    Time frame: through study period, every 3-6 months

    Use the Anorexia Cachexia Subscale-12 (A/CS-12) to assess anorexia, and utilize the CASC-IN tool to evaluate whether the patient has cachexia. If cachexia is present, the cachexia scoring system (CASCO) should be used for further assessment of the cachexia stage.

  8. Sarcopenia

    Time frame: through study period, every 3-6 months

    Utilize the Simple Five-Item Scale (SARC-F) questionnaire to screen if the study subjects have sarcopenia.

  9. Frailty

    Time frame: through study period, every 3-6 months

    Assess frailty using the Liver Frailty Index (LFI). This index considers the following assessment items: (1) Dominant hand grip strength; (2) Time to do 5 chair stands; and (3) Seconds holding 3 position balance.

Study contacts

Contact information is provided by the study sponsor or research team.

Aiping Fang, MBBS, PhD

CONTACT

[email protected]

+86 20 87335189

Yaojun Zhang, MBBS, MD

CONTACT

[email protected]

+86 20 87343117

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

Liver CAncer PRognosis InvEstigation Study (Liver-CARE)

Important dates

Study start
2025
Primary completion
2039
Study completion
2044
First posted
Oct 2, 2024
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.