Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06544083
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-04-16
Brief Title:
Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Early-stage Detection of Liver Cancer by Proteins in Peripheral Blood a Prospective Study
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
By collecting blood samples from liver cancer patients and healthy individuals and comparing the blood protein profiles of the two the biomarkers for early diagnosis and tissue traceability were identified to accurately establish an early diagnosis model for liver cancer and verify its efficacy
Detailed Description:
This study is a prospective study to establish an early diagnosis model for the diagnosis of liver cancer based on peripheral blood protein indexes and verify its efficacy
The study was divided into two phases model establishment and model validation In the model establishment stage blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were prospectively collected and in the model validation stage blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were included in multiple centers and a single-blind setting analyst blinding was carried out The diagnosis follow-up treatment and follow-up of subjects with cancer and benign lesions follow the routine clinical diagnosis and treatment procedures of the research center and are not affected by this study Healthy subjects undergo clinical examination in healthy persons according to the protocol of this study The follow-up diagnosis treatment and follow-up of subjects judged to be cancer suspected cancer benign lesions and suspected benign lesions during the clinical examination will follow the routine clinical diagnosis and treatment procedures of the research center and will not be affected by this study This study is expected to enroll 300 subjects including 100 subjects with liver cancer 100 subjects with benign diseases and 100 healthy subjects The study is divided into two phases and the first phase of the study will enroll 150 subjects including 50 subjects with liver cancer 50 subjects with benign disease and 50 healthy subjects The second phase of the study will enroll 150 subjects including 50 cancer subjects 50 benign disease subjects and 50 healthy subjects
The study was divided into two phases model establishment and model validation In the model establishment stage blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were prospectively collected and in the model validation stage blood samples from subjects with liver cancer and corresponding benign lesions and healthy subjects were included in multiple centers and a single-blind setting analyst blinding was carried out The diagnosis follow-up treatment and follow-up of subjects with cancer and benign lesions follow the routine clinical diagnosis and treatment procedures of the research center and are not affected by this study Healthy subjects undergo clinical examination in healthy persons according to the protocol of this study The follow-up diagnosis treatment and follow-up of subjects judged to be cancer suspected cancer benign lesions and suspected benign lesions during the clinical examination will follow the routine clinical diagnosis and treatment procedures of the research center and will not be affected by this study This study is expected to enroll 300 subjects including 100 subjects with liver cancer 100 subjects with benign diseases and 100 healthy subjects The study is divided into two phases and the first phase of the study will enroll 150 subjects including 50 subjects with liver cancer 50 subjects with benign disease and 50 healthy subjects The second phase of the study will enroll 150 subjects including 50 cancer subjects 50 benign disease subjects and 50 healthy subjects
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None