Recurrent Liver Cancer: Reconceptualization and Reevaluation
NCT ID: NCT06430983
Last Updated: 2024-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
300 participants
OBSERVATIONAL
2024-07-01
2027-10-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Training Set for Recurrent Liver Cancer Patient
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.
No interventions assigned to this group
Validation Set for Recurrent Liver Cancer Patient
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.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Those who have received organ transplantation
* Non-HCC patients diagnosed with other tumors
* Patients with primary hepatocellular carcinoma complicated by other tumors
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nanjing Medical University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Yewei Zhang
Chief Physician
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
zhang yewei, doctor
Role: STUDY_CHAIR
Nanjing Medical University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Second Affiliated Hospital of Nanjing Medical University
Nanjing, Jiangsu, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
yewei zhang
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2024KY16401
Identifier Type: -
Identifier Source: org_study_id