NCT05336058Completed
Development of Free DNA Multi-target Methylated PCR for Auxiliary Diagnosis of Gastric Cancer
A Case-control, Non-intervention Study for Gastric Cancer Screening
Source: ClinicalTrials.gov · Last updated 22 Apr 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1140 (actual)
- First submitted
- 25 Mar 2022
- Start date
- 1 Feb 2022
- Primary completion date
- 4 Feb 2024
- Lead sponsor
- Singlera Genomics Inc.
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT05336058
What you commit to
- Study type: Observational
- Participants enrolled: 1140
- From 1 Feb 2022 to the primary completion date, 4 Feb 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous digestive system tumors, including gastric cancer, esophageal cancer, colorectal cancer, liver cancer, etc.;
- 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
- have participated in an "interventional" clinical trial within the past 30 days and have taken the experimental drug;
Other illness
- 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;
- Participants in other interventional clinical researchers, pregnant or lactating women, or patients with autoimmune diseases, genetic diseases, mental diseases, etc., within 3 months.
- patients with other diseases deemed unsuitable for inclusion by the investigator;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fudan University Cancer hospital Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.