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Exploration and Identification of Early Gastric Cancer Biomarkers via the Disposable non-invasive sampler

Exploration and Identification of Early Gastric Cancer Biomarkers via the Disposable non-invasive sampler

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2500098288
Enrollment
Unknown
Registered
2025-03-05
Start date
2025-03-15
Completion date
Unknown
Last updated
2025-03-10

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

Conditions

Gastric Cancer

Interventions

Gastric Cancer Group:None. The enrolled volunteers underwent sample collection in accordance with the standard operating procedure outlined in the instruction manual of the "Disposable Non-invasive Ga
Gastric Ulcer Group:None. The enrolled volunteers underwent sample collection in accordance with the standard operating procedure outlined in the instruction manual of the "Disposable Non-invasive Gas
Atrophic Gastritis Group:None. The enrolled volunteers underwent sample collection in accordance with the standard operating procedure outlined in the instruction manual of the "Disposable Non-invasiv
Intestinal Metaplasia Group:None. The enrolled volunteers underwent sample collection in accordance with the standard operating procedure outlined in the instruction manual of the "Disposable Non-inva
Healthy Volunteer Group:None. The enrolled volunteers underwent sample collection in accordance with the standard operating procedure outlined in the instruction manual of the "Disposable Non-invasive

Sponsors

Department of Gastroenterology,Shenzhen Second People’s Hospital, Shenzhen, China
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: General Inclusion Criteria: Age between 18 and 60 years old, with voluntary participation in the study and signed informed consent. Group-specific Inclusion Criteria: (1)Gastric Cancer Group: Gastric cancer was clinically and pathologically staged according to the TNM staging system (AJCC/UICC). Early-stage gastric cancer includes severe dysplasia, carcinoma in situ, Stage I, and some Stage II cases. Advanced gastric cancer mainly includes Stage III and IV cases. Advanced gastric cancer was further classified endoscopically according to the Borrmann classification into Type I (polypoid), Borrmann II (ulcerative), Borrmann III (infiltrative), and Borrmann IV (diffuse infiltrative) . (2)Gastric Ulcer Group: Gastric ulcers were classified according to the Artificial Helicobacter pylori Staging (AHS) system into active stage (A), healing stage (H), and scar stage (S) . (3)Atrophic Gastritis Group: Participants were included in the atrophic gastritis group according to the updated Sydney System classification. The extent and severity of atrophy were assessed using the Operative Link for Gastritis Assessment (OLGA), with atrophic gastritis classified into Stages I–IV . (4)Intestinal Metaplasia Group: Participants with a confirmed diagnosis of intestinal metaplasia were included. The grading of intestinal metaplasia (GIM) was assessed using the Operative Link on Gastric Intestinal Metaplasia Assessment (OLGIM) scoring system, which classifies intestinal metaplasia into Stages I–IV . (5)Healthy Control Group: Healthy volunteers who underwent endoscopic screening at our hospital.

Exclusion criteria

Exclusion criteria: (1)A history of total or partial gastrectomy. (2)Presence of other gastrointestinal diseases (e.g., inflammatory bowel disease, other types of gastritis, etc.). (3)Women who are pregnant or breastfeeding. (4)History of oral medication use, including antibiotics or proton pump inhibitors (PPIs), within one month prior to undergoing endoscopy. (5)Presence of acute upper gastrointestinal bleeding or perforation. (6)Presence of severe comorbid conditions involving the heart, brain, lungs, liver, kidneys, or other major organs.

Design outcomes

Primary

MeasureTime frame
Specific microRNA Screening;

Secondary

MeasureTime frame
Specific Proteomics Biomarker Screening;

Countries

China

Contacts

Public ContactXiangyu Wang

Shenzhen Second People’s Hospital, Shenzhen, China

xiangyuwangsz@163.com+86 186 8223 1703

Outcome results

None listed

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