Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06367049
Status:
COMPLETED
Last Update Posted:
2024-04-16
First Post:
2024-03-27
Brief Title:
Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Nasopharyngeal carcinoma is one of the most common malignant tumors in China with the progress of radiochemical comprehensive treatment early stage The 5-year survival rate of nasopharyngeal cancer is more than 95 However due to the hidden site of nasopharyngeal carcinoma and the lack of obvious early clinical symptoms more than 70 of the 87000 newly diagnosed cases each year belong to the advanced stage of nasopharyngeal carcinoma and the 5-year survival rate of advanced nasopharyngeal carcinoma is only about 70 Therefore early screening and diagnosis and early treatment are the key to improve the survival of patients with nasopharyngeal cancer Selecting a sensitive and accurate biomarker for nasopharyngeal cancer and relying on a simple and feasible examination method for sampling detection will greatly improve the early diagnosis rate of nasopharyngeal cancer
DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression The main role of DNA methylation is to regulate gene expression Tumor suppressor genes play the functions of regulating cell differentiation maturation and programmed death However if methylation of promoter region occurs the expression of tumor suppressor genes is inhibited and the function is lost resulting in cells remaining in the stage of low differentiation and proliferation inhibition of apoptosis formation of blood vessels by cluster cells loss of cell adhesion and formation of tumors It can be seen that DNA methylation occurs in the early stage of tumor and this biological feature makes it a strong application prospect in early tumor screening
There are many methods to detect DNA Methylation among which methylation-specific PCR MSP can easily and quickly determine the methylation status of a specific gene meeting the affordable convenient and easy to generalize characteristics required for screening tests In combination with previous MSP experiments and previous reports we found that the methylation levels of promoter fragments of H4C6 Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma
Therefore this study intends to detect the methylation status of H4C6 Septin9 and RASSF1A genes based on MSP method with simple operation and low cost Using clinicopathological diagnosis as the gold standard the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer
DNA methylation is a form of chemical modification of DNA that can be done without altering the DNA sequence changes in genetic expression The main role of DNA methylation is to regulate gene expression Tumor suppressor genes play the functions of regulating cell differentiation maturation and programmed death However if methylation of promoter region occurs the expression of tumor suppressor genes is inhibited and the function is lost resulting in cells remaining in the stage of low differentiation and proliferation inhibition of apoptosis formation of blood vessels by cluster cells loss of cell adhesion and formation of tumors It can be seen that DNA methylation occurs in the early stage of tumor and this biological feature makes it a strong application prospect in early tumor screening
There are many methods to detect DNA Methylation among which methylation-specific PCR MSP can easily and quickly determine the methylation status of a specific gene meeting the affordable convenient and easy to generalize characteristics required for screening tests In combination with previous MSP experiments and previous reports we found that the methylation levels of promoter fragments of H4C6 Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues were significantly higher than those in healthy human nasopharyngeal tissues This suggests that methylation of these three genes may be used as biomarkers for early screening and diagnosis of nasopharyngeal carcinoma
Therefore this study intends to detect the methylation status of H4C6 Septin9 and RASSF1A genes based on MSP method with simple operation and low cost Using clinicopathological diagnosis as the gold standard the value of this gene methylation index in early screening and early diagnosis of nasopharyngeal cancer was verified providing a new detection index and method for improving the early diagnosis rate of nasopharyngeal cancer
Detailed Description:
None
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