Clinical trial NCT06430983: Recurrent Liver Cancer: Reconceptualization and Reevaluation
Official title: Recurrent Liver Cancer: Reconceptualization and Reevaluation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Recurrent Liver Cancer
Primary Liver Cancer
Keywords: Recurrent Liver Cancer
Primary Liver Cancer
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2024-05-28
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: As part of the patient registry, investigators will implement the following registration procedures and other quality factors:

Screening and Recruitment: Eligible patients will be screened and recruited through hospital liver cancer outpatient clinics and wards. Patients must meet the diagnostic criteria for recurrent or primary liver cancer and be willing to participate in the study.

Data Collection: Clinical information of participants will be collected, including demographic characteristics, medical history, treatment regimens, and follow-up outcomes. Data will be entered and verified by professionals to ensure accuracy and completeness.

Quality Control: Strict quality control measures will be implemented, including data audits, sample management, and laboratory testing. Regular reviews and validations of the data will be conducted to ensure the reliability and replicability of the study results.

Data Security: The privacy and personal information of participants will be protected. All data will be stored in a secure environment and comply with relevant laws, regulations, and ethical guidelines.

Ethical Review: The research protocol has been approved by the ethics committee, ensuring that the conduct of the study meets ethical standards and the protection of patient rights.

Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* Pregnant women
* Those who have received organ transplantation
* Non-HCC patients diagnosed with other tumors
* Patients with primary hepatocellular carcinoma complicated by other tumors
* Those judged by the researcher as not meeting the inclusion criteria

Primary outcomes:
measure: Sensitivity and Specificity of the Novel Protein Indicator
timeFrame: Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.
measure: Positive and Negative Predictive Values
timeFrame: Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).
measure: Progression-Free Survival (PFS)
timeFrame: 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).
measure: Disease-Free Survival (DFS)
timeFrame: Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).
measure: Time to Progression (TTP)
timeFrame: 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).
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: zhang yewei, doctor
role: STUDY_CHAIR
References: