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Clinical validation of Digital Spatial Profiler-based pathologic diagnostic markers for intestinal metaplasia-gastric cancer risk stratification

Clinical validation of Digital Spatial Profiler-based pathologic diagnostic markers for intestinal metaplasia-gastric cancer risk stratification

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2400084693
Enrollment
Unknown
Registered
2024-05-23
Start date
2024-05-31
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

gastric cancer

Interventions

Gold Standard:The histopathological diagnosis results refer to the formulated by the Chinese Society of Gastroenterology in Shanghai in 2022
Index test:Immunohistochemical staining

Sponsors

Wangjing Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Cases where the same patient underwent two or more gastroscopies and received pathological diagnoses at the same hospital over the past 10 years from the date of sample selection from the pathology sample bank; (2) Cases are unrestricted by gender, aged between 18 and 75 years; (3) The first gastroscopic biopsy and pathological diagnosis of the cases confirmed chronic atrophic gastritis with intestinal metaplasia in the gastric antrum; (4) The most recent gastroscopic biopsy and pathological diagnosis of the cases confirmed chronic atrophic gastritis with intestinal metaplasia in the gastric antrum, with an interval of at least 5 years since the initial diagnosis; (5) Or, the most recent gastroscopic biopsy and pathological diagnosis of the cases confirmed severe dysplasia, carcinoma in situ, or gastric cancer, with an interval of at least six months since the initial diagnosis; (6) The biopsy site for the cases included the gastric antrum and had not undergone standardized treatment.

Exclusion criteria

Exclusion criteria: (1) Cases with a history of gastric surgery; (2) Cases initially diagnosed with concurrent diseases other than intestinal metaplasia of the gastric antrum, such as regenerative hyperplasia, atypical hyperplasia, intraepithelial neoplasia, gastric cancer, etc.; (3) Cases with gastrointestinal ulcers, suspected malignancy, confirmed malignancy, or diagnosed with metastatic tumors; (4) Cases with severely incomplete clinical medical records.

Design outcomes

Primary

MeasureTime frame
Potential pathological diagnostic biomarkers for risk stratification of chronic atrophic gastritis with intestinal metaplasia in the gastric antrum;Histopathological changes;

Secondary

MeasureTime frame
Medical records include: age, gender, ethnicity, occupation, etc.; family history, allergy history, past medical history, etc.; body temperature, resting heart rate, respiration, blood pressure, gastroscopic images, pathological data, etc.;Risk factors: medication history, dietary habits, smoking history, bile reflux, HP (Helicobacter pylori) infection, etc.;

Countries

China

Contacts

Public ContactPing Zhang

Wangjing Hospital, China Academy of Chinese Medical Sciences

pinglele@sina.com+86 136 0138 2826

Outcome results

None listed

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