NCT07782294Not yet recruiting
AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis
Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer
Source: ClinicalTrials.gov · Last updated 24 Aug 2026
Brief summary (registry, in English)
The goal of this clinical trial is to prospectively validate the diagnostic performance of an rbcDNA-based assay for gastric cancer detection in individuals undergoing upper gastrointestinal endoscopy. The study aims to evaluate the diagnostic accuracy of rbcDNA in distinguishing newly diagnosed, treatment-naïve gastric cancer from non-cancerous gastric conditions, using endoscopic and histopathological findings as the reference standard. The study will also compare the diagnostic performance of the rbcDNA-based approach with currently available clinical biomarkers, including serum tumor markers, Helicobacter pylori testing, and pepsinogen-related indices. All enrolled participants will provide a 2 mL peripheral blood sample for rbcDNA analysis.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 542 (estimated)
- First submitted
- 29 Jul 2026
- Start date
- 1 Sept 2026
- Primary completion date
- 31 Dec 2027
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT07782294
What you commit to
- Study type: Observational
- Planned participants: 542
- From 1 Sept 2026 to the primary completion date, 31 Dec 2027
- 3 sites 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.
Who the study is looking for
- Age between 18 and 75 years.
- Scheduled for upper gastrointestinal endoscopy for the assessment of gastric diseases, including gastric cancer (stage I-IV), gastric precancerous lesions, and other benign gastric disorders.
- No previous treatment for the current gastric disease prior to blood collection, including surgery, chemotherapy, radiotherapy, immunotherapy and other anti-tumor therapies.
- Able and willing to participate and provide written informed consent. Exclusion Criteria
- Receiving therapeutic gastroscopy or endoscopic resection for gastric lesions diagnosed in other institutions.
- Presence of conditions that hinder complete gastric endoscopic visualization and reliable lesion evaluation, such as gastric retention and severe esophageal stenosis.
- History of other malignant tumors, prior anti-tumor treatment, or partial/total gastrectomy.
- Severe hemodynamic instability, malignant arrhythmia, unstable cardiovascular diseases, or recent major surgery.
- Hematological disorders, recent blood transfusion history, severe active infection, chronic infectious diseases (e.g., HIV), or severe systemic inflammation affecting blood cell composition.
- Pregnant or breastfeeding women.
- Enrolled in other concurrent clinical trials that may affect the current study results.
- Refusal to sign informed consent or failure to comply with study procedures.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Anyang Tumor Hospital Coordinator of this site? Confirm its status | Anyang | China | Unknown status |
| Second Affiliated Hospital, School of Medicine, Zhejiang University Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| Renji Hospital, Shanghai Jiaotong University School of Medicine Coordinator of this site? Confirm its status | Shanghai | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.