Recurrent Liver Cancer: Reconceptualization and Reevaluation
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorNanjing Medical University
About this trial
The goal of this observational study is to determine if a specific protein can serve as a novel indicator for the recurrence of liver cancer. The study will focus on recurrent liver cancer patients and compare participants to primary liver cancer patients as controls. The primary purpose is to assess whether the elevated levels of this protein can be used to monitor the recurrence of liver cancer.
The main questions it aims to answer are:
Is the levels of the protein significantly elevated in recurrent liver cancer patients compared to primary liver cancer patients? Can the protein be used as a reliable biomarker for the early detection of liver cancer recurrence?
Researchers will compare the protein levels in the following groups:
50 recurrent liver cancer patients (training set) with abnormally high levels of the protein.
250 recurrent liver cancer patients (validation set) to confirm the protein's elevation in a separate cohort.
Participants will be required to:
* Provide blood samples for protein analysis. * Undergo regular follow-up visits for monitoring and data collection. * Allow access to their medical records for relevant clinical information.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Diagnosed with primary hepatocellular carcinoma or diagnosed with non-HCC
The patient or the patient's legal representative must be able to read, understand, and sign the informed consent form
Agree to provide blood samples and have good clinical compliance
Complete clinical basic information, including: the patient's unique traceability number (ID card number/outpatient number/health insurance card number), age, gender, imaging and/or pathological diagnosis results (for patients with primary liver disease), imaging examination confirmed heteromorphic liver cancer (for non-HCC patients)
Disqualifiers
Pregnant women
Those who have received organ transplantation
Non-HCC patients diagnosed with other tumors
Patients with primary hepatocellular carcinoma complicated by other tumors
Trial population
The study population includes patients with primary hepatocellular carcinoma (HCC) and non-HCC liver cancers. Inclusion criteria are: diagnosis of primary HCC or non-HCC, ability to provide informed consent, agreement to supply blood samples, and clinical data completeness. Exclusion criteria include pregnancy, organ transplantation, other tumor diagnoses in non-HCC patients, HCC with other tumors, and researcher-determined ineligibility. The sample size is limited to ensure data precision and study validity.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
300 Participants
are grouped into 2 trial groupsGroup A: Training Set for Recurrent Liver Cancer Patient
Group B: Validation Set for Recurrent Liver Cancer Patient
Trial outcomes
Primary outcomes
1
Sensitivity and Specificity of the Novel Protein Indicator
The primary outcome is to determine the sensitivity and specificity of the novel protein indicator in predicting the recurrence of liver cancer. This will be assessed by constructing a Receiver Operating Characteristic (ROC) curve and establishing a threshold value that maximizes the true positive rate (sensitivity) and minimizes the false positive rate (1-specificity). The ROC curve will visually represent the trade-off between sensitivity and specificity for different threshold values.
Time frame
Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.2
Positive and Negative Predictive Values
The secondary outcome is to calculate the positive predictive value (PPV) and negative predictive value (NPV) of the novel protein indicator. The PPV represents the probability that patients with an elevated indicator level will experience cancer recurrence, while the NPV represents the probability that patients with a non-elevated indicator level will remain free of recurrence. These values will provide insight into the clinical utility of the indicator.
Time frame
Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).Secondary outcomes
1
Overall Survival (OS)
Overall survival (OS) is a critical endpoint that measures the length of time from the start of the study until the death of a patient. It provides an assessment of the long-term outcome for patients with liver cancer and will be used to evaluate the prognostic value of the novel protein indicator.
Time frame
Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).2
Progression-Free Survival (PFS)
Progression-free survival (PFS) is the length of time during and after the treatment of a disease that a patient lives without the disease getting worse. In the context of this study, PFS will be used to measure the time from study entry until the cancer progresses or the patient dies from any cause, providing an intermediate endpoint that reflects the control of disease progression.
Time frame
Assessed at each follow-up visit, every 3 months for the first 2 years, then every 6 months until study completion (up to 5 years).3
Disease-Free Survival (DFS)
Disease-free survival (DFS) is the period after treatment during which there is no evidence of active cancer. It is a measure of the effectiveness of treatment in eliminating cancer cells. DFS will be calculated from the time of treatment initiation until the first sign of cancer recurrence or the end of the study.
Time frame
Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).4
Time to Progression (TTP)
Time to progression (TTP) is the interval from the start of treatment until the tumor progresses or the patient's condition worsens to a defined level. This endpoint is particularly relevant for evaluating the effectiveness of the novel protein indicator in predicting and monitoring disease progression.
Time frame
Measured from the initiation of the study intervention until progression or defined worsening, assessed at each follow-up visit (every 3 months for the first 2 years, then every 6 months until study completion, up to 5 years).Sponsors and contacts
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Source ClinicalTrials.gov