The classic website will no longer be available as of June 25, 2024. Please use the modernized
Working… Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT05336058
Recruitment Status : Completed
First Posted : April 20, 2022
Last Update Posted : April 22, 2024
Fudan University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Stomach Cancer Other: No intervention

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 1140 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Case-control, Non-intervention Study for Gastric Cancer Screening
Actual Study Start Date : February 1, 2022
Actual Primary Completion Date : February 4, 2024
Actual Study Completion Date : February 4, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

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

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

Primary Outcome Measures :
  1. Sensitivity and specificity of methylation detection in gastric cancer [ Time Frame: assessed up to 12 months ]
    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.

  2. Comparison of polygene methylation detection and other serological detection methods in gastric cancer [ Time Frame: assessed up to 12 months ]
    The specificity and sensitivity of multigene methylation (PCR-fluorescence probe) and CA199, CEA and CA724 in the auxiliary diagnosis of gastric cancer were compared.

  3. Screening of genetic targets for kit development [ Time Frame: assessed up to 12 months ]
    The research data will provide a basis for screening gene targets for the development of subsequent detection kits.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05336058

Layout table for location information
China, Shanghai
Fudan University Cancer Hospital
Shanghai, Shanghai, China, 200000
Sponsors and Collaborators
Singlera Genomics Inc.
Fudan University
Layout table for investigator information
Principal Investigator: Rui Liu, PhD Singlera Genomics Inc.
Layout table for additonal information
Responsible Party: Singlera Genomics Inc. Identifier: NCT05336058    
Other Study ID Numbers: 2201249-17
First Posted: April 20, 2022    Key Record Dates
Last Update Posted: April 22, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Singlera Genomics Inc.:
DNA methylation
Early gastric cancer screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases