Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma

Nasopharyngeal Carcinoma Clinical Trial

Official title:

Methylation-specific PCR Test for Early Screening and Early Diagnosis of Nasopharyngeal Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06367049
• Other study ID #: 2023-FXY-230-NPC
• Status: Completed
• Start date: June 1, 2023
• Est. completion date: March 1, 2024

Study information

• Verified date: March 2024
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 470
• Est. completion date: March 1, 2024
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Disease
• Nasopharyngeal Carcinoma

Intervention

Diagnostic Test:
• Methylation-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.

Locations

Country	Name	City	State
China	Sun yat-sen University Cancer Center	Guangzhou	Guangdong

Sponsors (3)

Lead Sponsor	Collaborator
Sun Yat-sen University	Affiliated Cancer Hospital & Institute of Guangzhou Medical University, Guangdong Women and Children Hospital

Country where clinical trial is conducted

China, 

References & Publications (21)

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* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	The proportion of patients with pathological diagnosis of nasopharyngeal carcinoma with positive methylation index.	through study completion, an average of 1 year
Secondary	Specificity	The proportion of non-nasopharyngeal carcinoma patients with negative methylation index.	through study completion, an average of 1 year