Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430983
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-16
Brief Title:
Recurrent Liver Cancer Reconceptualization and Reevaluation
Sponsor:
Nanjing Medical University
Organization:
Nanjing Medical University
Study Overview
Official Title:
Recurrent Liver Cancer Reconceptualization and Reevaluation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 proteins 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
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 proteins 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None