Recurrent Liver Cancer: Reconceptualization and Reevaluation

NCT06430983 | Recruiting

• 1 other identifier: 2024KY16401
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Recurrent Liver Cancer; Primary Liver Cancer

Keywords

Recurrent Liver Cancer; Primary Liver Cancer

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed at the end of the study (up to 3 years), once all patient data has been collected and analyzed.

• 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.

  Calculated after the threshold value has been determined and applied to the patient data (up to 3 years).

Secondary Outcomes (4)

• Overall Survival (OS)

  Monitored throughout the study and reported at 1 year, 2 years, and study completion (up to 5 years).

• Progression-Free Survival (PFS)

  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).

• Disease-Free Survival (DFS)

  Monitored and reported at 6 months, 1 year, 2 years, and study completion (up to 5 years).

• Time to Progression (TTP)

  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).

Study Arms (2)

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.

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.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• Pregnant women
• Those who have received organ transplantation
• Non-HCC patients diagnosed with other tumors
• Patients with primary hepatocellular carcinoma complicated by other tumors

Sponsors & Collaborators

• Nanjing Medical University: lead

Study Sites (1)

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Conditions

Liver Neoplasms; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Liver Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• zhang yewei, doctor

  Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

zhang yewei, doctor

CONTACT

+86 13813885788; zhangyewei@njmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Physician

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 28, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): October 1, 2027
• Last Updated: December 12, 2024

Record last verified: 2024-12

Locations

CN (1)