AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis

NCT07782294 | Not Yet Recruiting

• 1 other identifier: 2026-0523
• Study Type: observational
• Target: 542
• Locations: 1 country
• Sites: 3

Brief Summary

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

Gastric Cancer

Keywords

Gastric cancer; rbcDNA; Early detection

Outcome Measures

Primary Outcomes (3)

• Sensitivity of the rbcDNA blood test for gastric cancer screening

  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.

  Through study completion, an average of 1 year

• Specificity of the rbcDNA blood test for gastric cancer screening

  Specificity is defined as the percentage of participants without gastric cancer (with other benign gastric disorders) who have a negative rbcDNA test result. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation. Higher specificity indicates fewer false-positive test results.

  Through study completion, an average of 1 year

• Overall accuracy of the rbcDNA blood test for gastric cancer screening

  Overall accuracy is defined as the percentage of all enrolled participants whose rbcDNA test result matches the final clinical-pathological gastric disease diagnosis. Final pathological diagnosis from standard hospital clinical examination serves as the gold-standard reference for calculation.

  Through study completion, an average of 1 year

Secondary Outcomes (3)

• Sensitivity of conventional gastric cancer screening tests

  Through study completion, an average of 1 year

• Specificity of conventional clinical gastric cancer screening tests

  Through study completion, an average of 1 year

• Overall accuracy of conventional clinical gastric cancer screening tests

  Through study completion, an average of 1 year

Study Arms (2)

GC group

Subjects with histopathologically confirmed gastric cancer (stage I-IV)

Contol group

Non-gastric cancer subjects, including superficial gastritis, gastric ulcer, adenomatous gastric polyps, atrophic gastritis, intestinal metaplasia, etc.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Participants consist of patients with gastric diseases undergoing gastroscopy, enrolled from three different medical centers across China.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, Zhejiang University, School of Medicine: lead
• Anyang Tumor Hospital: collaborator
• RenJi Hospital: collaborator

Study Sites (3)

Anyang Tumor Hospital

Anyang, Henan, 455000, China

Location

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310009, China

Location

Renji Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, 200001, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Yuehua Han

  Second Affiliated Hospital, Zhejiang University, School of Medicine

  STUDY CHAIR

Central Study Contacts

Yuehua Han

CONTACT

+86 13858126927; 13858126927@163.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 24, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)