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

Stomach Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05336058
• Other study ID #: 2201249-17
• Status: Completed
• Start date: February 1, 2022
• Est. completion date: February 4, 2024

Study information

• Verified date: April 2024
• Source: Singlera Genomics Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1140
• Est. completion date: February 4, 2024
• Est. primary completion date: February 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Stomach Cancer
• Stomach Neoplasms

Intervention

Other:
• No intervention
In this non-intervention study, 10ml of whole blood of enrolled subjects was collected for multi-target PCR detection of cfDNA methylation.

Locations

Country	Name	City	State
China	Fudan University Cancer Hospital	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Singlera Genomics Inc.	Fudan University

Country where clinical trial is conducted

China, 

References & Publications (3)

Chen X, Gole J, Gore A, He Q, Lu M, Min J, Yuan Z, Yang X, Jiang Y, Zhang T, Suo C, Li X, Cheng L, Zhang Z, Niu H, Li Z, Xie Z, Shi H, Zhang X, Fan M, Wang X, Yang Y, Dang J, McConnell C, Zhang J, Wang J, Yu S, Ye W, Gao Y, Zhang K, Liu R, Jin L. Non-invasive early detection of cancer four years before conventional diagnosis using a blood test. Nat Commun. 2020 Jul 21;11(1):3475. doi: 10.1038/s41467-020-17316-z. — View Citation

Guo S, Diep D, Plongthongkum N, Fung HL, Zhang K, Zhang K. Identification of methylation haplotype blocks aids in deconvolution of heterogeneous tissue samples and tumor tissue-of-origin mapping from plasma DNA. Nat Genet. 2017 Apr;49(4):635-642. doi: 10.1038/ng.3805. Epub 2017 Mar 6. — View Citation

Yu G, Wang GX, Wang HG, Mo FF, Tang BB. The value of detecting pepsinogen and gastrin-17 levels in serum for pre-cancerous lesion screening in gastric cancer. Neoplasma. 2019 Jul 23;66(4):637-640. doi: 10.4149/neo_2018_180825N647. Epub 2019 Apr 24. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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