Ignite Creation Date:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 11:32 PM
Study NCT ID:
NCT05668793
Status:
UNKNOWN
Last Update Posted:
2022-12-30
First Post:
2022-12-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
GNB4 and Riplet Gene Methylation Combined Detection Kit (Fluorescence PCR Method)
Sponsor:
Wuhan Ammunition Life-tech Co., Ltd
Organization:
Study Overview
Official Title:
Methylation Detection of KCNA3 and OTOP2 Genes in Plasma for the Auxiliary Diagnosis of Hepatocellular Carcinoma: a Clinical Trial
Status:
UNKNOWN
Status Verified Date:
2022-12
Last Known Status:
NOT_YET_RECRUITING
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 test the clinical efficacy of "GNB4 and Riplet gene methylation combined detection kit (fluorescence PCR method)"in hepatocellular carcinoma auxiliary diagnosis. The main questions it aims to answer are:
1. How consistent are the test results of the kit with the clinical reference diagnostic criteria?
2. Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting GNB4 and Riplet gene methylation.
Each participant is required to provide no less than 10 ml of blood to complete the kit test.
1. How consistent are the test results of the kit with the clinical reference diagnostic criteria?
2. Sanger sequencing can visually show whether each sample contains methylation sites, so in this clinical trial, the kit results were compared with Sanger sequencing results to analyze the reagent's accuracy in detecting GNB4 and Riplet gene methylation.
Each participant is required to provide no less than 10 ml of blood to complete the kit test.
Detailed Description:
1. Before the start of clinical trials, investigators will be uniformly trained by experts from the clinical trial institutions or from the sponsor. Researchers should be familiar with and correctly operated the test kits and instruments.
2. Throughout the clinical trial process, the clinical trial institution should ensure that it follows the scheduled protocal and strictly abide by the instructions of instruments and reagents.
3. The entire trial process should be completed by the researchers in the laboratory of the clinical trial institution. Except for the necessary guidance, the technical staff of the sponsor shall not interfere with the experimental process at will, especially data collection process. Blind methods should be used to ensure the objectivity of the test results.
4. The sponsor shall ensure that the test reagents are qualified, and transported to the clinical institution in accordance with the transportation conditions in the manual. Researchers should record the information of receipt, storage, use, handling and recycling process.
5. Researchers should ensure that the clinical trial data are recorded accurately, completely, clearly and in a timely manner. Any changes to the data should be signed and dated by the researcher, and the original records should be kept. The original records should be clear and recognizable. All observations and findings in clinical trials should be truthfully recorded and verified to ensure the reliability of the data and to ensure that the conclusions of clinical trials are derived from the original records.
2. Throughout the clinical trial process, the clinical trial institution should ensure that it follows the scheduled protocal and strictly abide by the instructions of instruments and reagents.
3. The entire trial process should be completed by the researchers in the laboratory of the clinical trial institution. Except for the necessary guidance, the technical staff of the sponsor shall not interfere with the experimental process at will, especially data collection process. Blind methods should be used to ensure the objectivity of the test results.
4. The sponsor shall ensure that the test reagents are qualified, and transported to the clinical institution in accordance with the transportation conditions in the manual. Researchers should record the information of receipt, storage, use, handling and recycling process.
5. Researchers should ensure that the clinical trial data are recorded accurately, completely, clearly and in a timely manner. Any changes to the data should be signed and dated by the researcher, and the original records should be kept. The original records should be clear and recognizable. All observations and findings in clinical trials should be truthfully recorded and verified to ensure the reliability of the data and to ensure that the conclusions of clinical trials are derived from the original records.
Study Oversight
Has Oversight DMC:
True
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?: