Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer
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ClinicalTrials.gov Identifier: NCT05336058 |
Recruitment Status :
Completed
First Posted : April 20, 2022
Last Update Posted : April 22, 2024
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Condition or disease | Intervention/treatment |
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Stomach Cancer | Other: No intervention |
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 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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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. |
- 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.
- 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.
- 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.
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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 |
Inclusion Criteria:
- 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 Criteria:
- 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;
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 ClinicalTrials.gov identifier (NCT number): NCT05336058
China, Shanghai | |
Fudan University Cancer Hospital | |
Shanghai, Shanghai, China, 200000 |
Principal Investigator: | Rui Liu, PhD | Singlera Genomics Inc. |
Responsible Party: | Singlera Genomics Inc. |
ClinicalTrials.gov 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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
DNA methylation Early gastric cancer screening |
Stomach Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Stomach Diseases |