Liver NeoplasmsNCT06623734
Liver Cancer Prognosis Investigation Study
An observational study of Liver Neoplasms, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Liver Neoplasms
- How many people
- 5,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 31 Dec 2044
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients newly diagnosed with primary liver cancer
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Yaojun Zhang, MBBS, MD, +86 20 87343117, zhangyuj@sysucc.org.cn
About this study
Official title: Liver CAncer PRognosis InvEstigation Study (Liver-CARE)
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.
Read the 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.
- Conditions
- Liver Neoplasms
- Keywords
- Primary liver cancer, Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Prognosis, Prospective cohort study
- Medical subject headings
- Liver Neoplasms, Carcinoma, Hepatocellular, Cholangiocarcinoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
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.
Measured: Up to 20 years
Secondary outcomes (9)
Recurrence (intrahepatic and extrahepatic)
Time of recurrence will be obtained by telephone interview or medical treatment records
Measured: 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 of newly emerging diseases will be obtained by telephone interview or medical treatment records
Measured: 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
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.
Measured: through study period, every 3-6 months
Nutritional status
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).
Measured: through study period, every 3-6 months
Quality of life
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.
Measured: through study period, every 3-6 months
Psychological and mental status
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.
Measured: through study period, every 3-6 months
Cachexia assessment
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.
Measured: through study period, every 3-6 months
Sarcopenia
Utilize the Simple Five-Item Scale (SARC-F) questionnaire to screen if the study subjects have sarcopenia.
Measured: through study period, every 3-6 months
Frailty
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.
Measured: through study period, every 3-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2024
- Study start1 Apr 2025 (estimated)
- Primary completion31 Dec 2039 (estimated)
- Study completion31 Dec 2044 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver NeoplasmsStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aiping Fang, Sun Yat-sen University
- Investigators
- Aiping Fang, MBBS, PhD, Principal investigator, Sun Yat-sen UniversityYanjun Zhang, MBBS, MD, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06623734
- Sponsor's protocol ID
- SYSU SPH MEC 2024-101
- Status last verified
- Mar 2025
- First submitted
- 30 Sep 2024
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liver CAncer PRognosis InvEstigation Study (Liver-CARE)
- ClinicalTrials.gov ID
- NCT06623734
- Acronym / sponsor ID
- SYSU SPH MEC 2024-101
- Conditions
- Liver Neoplasms
- Keywords
- Primary liver cancer, Hepatocellular carcinoma, Intrahepatic cholangiocarcinoma, Prognosis, Prospective cohort study
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2025 (estimated)
- Primary completion
- 31 Dec 2039 (estimated)
- Study completion
- 31 Dec 2044 (estimated)
- First posted
- 2 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients newly diagnosed with primary liver cancer
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Aiping Fang, MBBS, PhD principal investigator
Sun Yat-sen University
Yanjun Zhang, MBBS, MD principal investigator
Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Neoplasms, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aiping Fang, MBBS, PhD (+86 20 87335189, fangaip@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: Up to 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.