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NCT Number: NCT07782294

AI-Assisted Novel rbcDNA Detection for Early Gastric Cancer Diagnosis

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Anyang Tumor Hospital, Anyang, Henan, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Sensitivity of the rbcDNA blood test for gastric cancer screening

    Time frame: Through study completion, an average of 1 year

    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.

  2. Specificity of the rbcDNA blood test for gastric cancer screening

    Time frame: Through study completion, an average of 1 year

    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.

  3. Overall accuracy of the rbcDNA blood test for gastric cancer screening

    Time frame: Through study completion, an average of 1 year

    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.

Secondary outcomes

  1. Sensitivity of conventional gastric cancer screening tests

    Time frame: Through study completion, an average of 1 year

    Percent of pathologically-confirmed gastric cancer participants with positive results from conventional screening assays, including serum tumor markers, Helicobacter pylori testing and pepsin-related indices. Calculated against final pathological gastric cancer diagnosis as unified gold standard.

  2. Specificity of conventional clinical gastric cancer screening tests

    Time frame: Through study completion, an average of 1 year

    Percent of participants without pathologically-confirmed gastric cancer with negative results from conventional screening assays, including serum tumor markers, Helicobacter pylori testing and pepsin-related indices. Calculated against final pathological gastric cancer diagnosis as unified gold standard.

  3. Overall accuracy of conventional clinical gastric cancer screening tests

    Time frame: Through study completion, an average of 1 year

    Proportion of all participants with consistent results from conventional screening assays relative to final pathological gastric cancer diagnosis (unified gold-standard reference). Conventional assays include serum tumor markers, Helicobacter pylori testing and pepsin-related indices.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuehua Han

CONTACT

[email protected]

+86 13858126927

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, Zhejiang University, School of Medicine

Other

Collaborators

  • Anyang Tumor Hospital
  • RenJi Hospital

Registry information

Official study title

Application Research of Artificial Intelligence-Assisted Novel Red Blood Cell DNA (rbcDNA) Detection for Early Diagnosis of Gastric Cancer

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 24, 2026
Registry last updated
Aug 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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