Official Title
A Case-control, Non-intervention Study for Gastric Cancer Screening
Brief Title
Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer
Protocol ID
NCT05336058
Lead Sponsor
Singlera Genomics Inc.
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.
Study Period
-
Enrollment Count
1,140 participants
Eligibility Criteria
Inclusion Criteria:
1. At least 18 years of age, no gender limitation;
2. those who can accept gastroscopy or provide pathological examination results of
postoperative gastric biopsy
3. 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;
4. 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:
1. Previous digestive system tumors, including gastric cancer, esophageal cancer,
colorectal cancer, liver cancer, etc.;
2. have a history of other cancers and have not been clinically cured (clinically
cured: no recurrence and metastasis within 5 years after surgery);
3. Systemic inflammatory response syndrome;
4. 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;
5. Those who have received major surgical treatment such as blood transfusion or
transplantation within 3 months
6. Participants in other interventional clinical researchers, pregnant or lactating
women, or patients with autoimmune diseases, genetic diseases, mental diseases,
etc., within 3 months.
7. have participated in an "interventional" clinical trial within the past 30 days and
have taken the experimental drug;
8. patients with other diseases deemed unsuitable for inclusion by the investigator;
Filters
Stomach Cancer
COMPLETED
ADULT
OLDER_ADULT