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

NCT05336058 | Completed

• 1 other identifier: 2201249-17
• Study Type: observational
• Target: 1,140
• Locations: 1 country
• Sites: 1

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.

Conditions

Stomach Cancer

Keywords

DNA methylation; Early gastric cancer screening

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Gastric cancer group

We anticipate enrolling approximately 620 gastric cancer (GC) cases, comprising 20 sets of GC tumors and their corresponding peritumoral tissue samples, as well as a minimum of 600 plasma samples from patients across stages I to IV of GC. Pathological diagnosis is required.

Other: No intervention

Negative group

A total of approximately 520 cases were included in the study, comprising 20 cases providing white blood cell samples from healthy individuals, and 500 patients diagnosed with gastric diseases other than gastric cancer (such as gastritis, atrophy, intestinal metaplasia, etc.), who provided plasma samples.

Other: No intervention

Interventions

No intervention OTHER

In this non-intervention study, 10ml of whole blood of enrolled subjects was collected for multi-target PCR detection of cfDNA methylation.

Gastric cancer group; Negative group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Eligible participants were recruited from the Department of Gastrosurgery, Fudan University Cancer Hospital, including gastric cancer, precancerous lesions of gastric cancer, other gastric lesions, no abnormalities in gastroscopy, and other cancers.

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Singlera Genomics Inc.: lead
• Fudan University: collaborator

Study Sites (1)

Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (3)

• 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.

  PMID: 31058531 BACKGROUND

• 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.

  PMID: 28263317 BACKGROUND

• 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.

  PMID: 32694610 BACKGROUND

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Rui Liu, PhD

  Singlera Genomics Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2022
• First Posted: April 20, 2022
• Study Start: February 1, 2022
• Primary Completion: February 4, 2024
• Study Completion: February 4, 2024
• Last Updated: April 22, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)