Liver Cancer Prognosis Investigation Study
ConditionLiver Neoplasms
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorSun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 population
Patients newly diagnosed with primary liver cancer
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 20 yearsSecondary outcomes
1
Recurrence (intrahepatic and extrahepatic)
Time of recurrence will be obtained by telephone interview or medical treatment records
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 years2
Newly Emerging Diseases
Time of newly emerging diseases will be obtained by telephone interview or medical treatment records
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 years3
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.
Time frame
through study period, every 3-6 months4
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).
Time frame
through study period, every 3-6 monthsSponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: