Recurrent Liver Cancer: Reconceptualization and Reevaluation

Nanjing Medical University

Status: Enrolling

Conditions: Primary Liver Cancer; Recurrent Liver Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06430983

2024KY16401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 2 patient groups

Training Set for Recurrent Liver Cancer Patient

Description:

The training set for recurrent liver cancer patients is a subset of data collected from individuals who have been diagnosed with liver cancer that has returned after a period of remission or initial treatment. This data set is used to train machine learning models or other statistical methods to identify patterns or biomarkers that are indicative of cancer recurrence. The training set typically includes information such as patient demographics, medical history, previous treatments, and biological data, such as genetic mutations, protein levels, or imaging results. The goal is to use this data to develop a model that can accurately predict the recurrence of liver cancer in other patients, which can then be validated and tested using a separate data set, known as the validation set.

Validation Set for Recurrent Liver Cancer Patient

Description:

The validation set for recurrent liver cancer patients is a distinct subset of data that is used to assess the performance and generalizability of a model or hypothesis developed from a training set. This set includes data from patients with recurrent liver cancer who were not part of the original training set. The purpose of the validation set is to test the model's ability to accurately predict or classify cases of recurrent liver cancer in a population that it has not been exposed to during its training phase.