Status:
COMPLETED
Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer
Lead Sponsor:
Singlera Genomics Inc.
Collaborating Sponsors:
Fudan University
Conditions:
Stomach Cancer
Eligibility:
All Genders
18+ years
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, i...
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 dif...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
February 1 2022
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2024
Estimated Enrollment :
1140 Patients enrolled
Trial Details
Trial ID
NCT05336058
Start Date
February 1 2022
End Date
February 4 2024
Last Update
April 22 2024
Active Locations (1)
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1
Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200000