Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer

Study Overview
=================
Brief Summary
-----------------
This was a case control, non-intervention study jointly developed by Fudan University Cancer Hospital and Shanghai Singlera Genomics Company. The enrolled population was screened by gastric surgery, including gastric cancer, precancerous lesions, benign lesions, and healthy control group. 10ml of whole blood of the enrolled subjects was collected for multi-target PCR detection of cfDNA methylation. The objective is to explore the clinical performance of polygene methylation (PCR-fluorescence probe) in the adjunctive diagnosis of gastric cancer, including the sensitivity of detection of various types and stages of gastric cancer, the specificity of detection of healthy controls, precancerous states, precancerous lesions, and the detection interference of other cancers. The diagnostic performance will be compared with CA199, CEA and CA724. The research data will provide a basis for screening targets for the development of detection kits.

Detailed Description
-----------------
Design and plan of the project: 1) Using the MONOD patent detection data of the company's previous research and combining with literature retrieval, analyze the tissue samples of gastric cancer of different stages and their paired paracancer tissues to screen the methylation mutation sites related to early gastric cancer and select the sites suitable for PCR detection; 2) ctDNA methylation markers in gastric cancer blood were preliminarily screened by plasma of healthy persons and preoperative plasma paired with tissues; 3) Using the screened blood ctDNA specific methylation markers, a targeted detection method for early gastric cancer lesions was designed; 4) The detection performance of the independent validation set sample confirmation establishment method.

Official Title
-----------------
A Case-control, Non-intervention Study for Gastric Cancer Screening

Conditions
-----------------
Stomach Cancer

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age, no gender limitation; those who can accept gastroscopy or provide pathological examination results of postoperative gastric biopsy Patients newly diagnosed with stage I-IV gastric adenocarcinoma who had not received surgery, radiotherapy, chemotherapy, targeted therapy or other anti-tumor intervention before blood collection; There were precancerous lesions and carcinoma in situ in the pathological examination of gastroscopy or esophageal biopsy, and no abnormalities in other gastric lesions, gastroscopy or other cancers. And no previous history of tumor disease. Exclusion Criteria: Previous digestive system tumors, including gastric cancer, esophageal cancer, colorectal cancer, liver cancer, etc.; have a history of other cancers and have not been clinically cured (clinically cured: no recurrence and metastasis within 5 years after surgery); Systemic inflammatory response syndrome; A history of severe cardiovascular disease (e.g., previous myocardial infarction, coronary artery bypass grafting, or coronary stenting); A history of congestive heart failure; Patients with myocardial infarction within 6 months, uncontrolled severe hypertension, etc.) who were deemed unsuitable for inclusion by the investigator; Those who have received major surgical treatment such as blood transfusion or transplantation within 3 months Participants in other interventional clinical researchers, pregnant or lactating women, or patients with autoimmune diseases, genetic diseases, mental diseases, etc., within 3 months. have participated in an interventional clinical trial within the past 30 days and have taken the experimental drug; patients with other diseases deemed unsuitable for inclusion by the investigator;

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Gastric cancer group<br>A total of about 500 cases are expected to be enrolled, including 150 cases in stage I and 100 cases in II-IV. Pathological diagnosis is required. | Other: No intervention<br>* In this non-intervention study, 10ml of whole blood of enrolled subjects was collected for multi-target PCR detection of cfDNA methylation.<br>|
| Negative group<br>A total of about 740 cases were included, including 400 cases without abnormal gastroscopy, 100 cases with other cancers, and 240 cases with precancerous gastric cancer and other lesions. | Other: No intervention<br>* In this non-intervention study, 10ml of whole blood of enrolled subjects was collected for multi-target PCR detection of cfDNA methylation.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and specificity of methylation detection in gastric cancer | To investigate the sensitivity and specificity of polygene methylation in the diagnosis of gastric cancer of different types and stages, and to evaluate its value as an auxiliary diagnosis. | assessed up to 12 months | 
| Comparison of polygene methylation detection and other serological detection methods in gastric cancer | The specificity and sensitivity of multigene methylation (PCR-fluorescence probe) and CA199, CEA and CA724 in the auxiliary diagnosis of gastric cancer were compared. | assessed up to 12 months | 
| Screening of genetic targets for kit development | The research data will provide a basis for screening gene targets for the development of subsequent detection kits. | assessed up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DNA methylation, Early gastric cancer screening