Early Diagnosis of Cancer, Nasopharyngeal Carcinoma
Conditions
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 87,000 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.
Interventions
DIAGNOSTIC_TESTMethylation-specific PCR
Methylation-specific PCR is the simplest and quickest method for qualitative detection of methylation status. The unmethylated C base is converted to U by bisulfite conversion, which is subsequently amplified by PCR with primers (methylation-specific and non-methylation-specific primers) and subsequently detected by agarose gel electrophoresis or a probe. The key to MSP is to design PCR primers for specific gene regions. The research team of this project has previously found the sequence sites of methylation of H4C6, Septin9 and RASSF1A genes in nasopharyngeal carcinoma tissues through methylation sequencing, and designed specific MSP amplification primers and probes accordingly, which can perform methylation detection easily and quickly.
Sponsors
Guangdong Women and Children Hospital
Affiliated Cancer Hospital & Institute of Guangzhou Medical University
Sun Yat-sen University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Case group (nasopharyngeal carcinoma group): nasopharyngeal carcinoma confirmed by histology or cytology. Control group (non-nasopharyngeal carcinoma group): no nasopharyngeal carcinoma subjects. 2. Age ≥18 years and ≤70 years. 3. No previous history of other tumors, and no current tumors.
Exclusion criteria
1. Karnofsky score ≤70 points or Zubrod score >2 points. 2. There are serious medical complications, dysfunction of important organs (heart, lung, liver, kidney) or neuropsychiatric disorders. 3. Other patients or volunteers deemed unsuitable for inclusion by the supervising physician.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity | through study completion, an average of 1 year | The proportion of patients with pathological diagnosis of nasopharyngeal carcinoma with positive methylation index. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Specificity | through study completion, an average of 1 year | The proportion of non-nasopharyngeal carcinoma patients with negative methylation index. |
Countries
China
Outcome results
None listed