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Diagnostic ability of the novel system based on 'pink zoon pattern' for early gastric cancer: a multicenter, prospective, randomized controlled study

Diagnostic ability of the novel system based on 'pink zoon pattern' for early gastric cancer: a multicenter, prospective, randomized controlled study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098666
Enrollment
Unknown
Registered
2025-03-12
Start date
2025-04-07
Completion date
Unknown
Last updated
2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Early Gastric Cancer

Interventions

Gold Standard:Histopathological diagnosis: All target lesions were biopsied or resected, and histopathological diagnosis was performed. The diagnostic procedure is evaluated by an experienced patholog
Index test:The study was designed to enroll 764 lesions suspected of being abnormal as identified by white light endoscopy. Patients with lesions observed using ME-NBI were randomly assigned in a 1:1

Sponsors

Zhejiang Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1.Patients with suspected lesions detected by conventional white light endoscopy requiring further endoscopic narrow-band imaging evaluation; 2. Age >=18 years old, gender is not limited; 3. ECOG score 0 or 1; 4. No previous tumor-related history; 5. Gastroscopy and pathological examination can be performed within 7 days after signing the informed consent; 6. Subject and family members are able to understand the study protocol and are willing to participate in the study, providing written informed consent.

Exclusion criteria

Exclusion criteria: 1. Patients who have previously undergone ESD/ partial gastrectomy; 2. A history of other neoplastic diseases, or other genetic diseases; 3. Patients with serious medical diseases, such as grade III or above cardiac dysfunction (NYHA criteria), ischemic heart disease, heart infarction, or angina pectoris, or heart infarction 6 months before screening, poorly controlled diabetes, poorly controlled hypertension, and echocardiographic ejection fraction 6mg/L; 6. The subject or family member is unable to understand the conditions and objectives of the study; 7. Accurate ME-NBI assessment cannot be performed on lesions and ulcers/erosions that are partially or completely obscured by excessive bleeding or mucus.

Design outcomes

Secondary

MeasureTime frame
The positive predicative value;The negative predicative value;

Primary

MeasureTime frame
The diagnostic sensitivity;The diagnostic specificity;

Countries

China

Contacts

Public ContactShi Wang

Zhejiang Cancer Hospital

wangshi@zjcc.org.cn+86 571 8812 2250

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026