Clinical trial · Observational
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- GC group
- description
- Subjects with histopathologically confirmed gastric cancer (stage I-IV)
- label
- Contol group
- description
- Non-gastric cancer subjects, including superficial gastritis, gastric ulcer, adenomatous gastric polyps, atrophic gastritis, intestinal metaplasia, etc.
Primary outcomes (3)
- measure
- Sensitivity of the rbcDNA blood test for gastric cancer screening
- timeFrame
- Through study completion, an average of 1 year
- description
- Sensitivity is defined as the percentage of participants with pathologically confirmed gastric cancer who have a positive rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher sensitivity indicates fewer true gastric cancer cases are missed by the test.
- measure
- Specificity of the rbcDNA blood test for gastric cancer screening
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria * 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.
References
Publications (0)
Data not yet available