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A Risk-Stratified, Graded Intervention Study for Gastric Precancerous Lesions

A Risk-Stratified, Graded Intervention Study for Gastric Precancerous Lesions

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600127828
Enrollment
Unknown
Registered
2026-07-08
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-07-13

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

Conditions

Gastric Cancer

Interventions

Conventional control group:Participants randomized to the conventional control group will be managed according to the current routine screening and follow-up surveillance strategy: (1) Participants wi
(2) Participants with low-grade intraepithelial neoplasia will undergo endoscopic screening and follow-up once every year.
Risk-stratified intervention group:A risk assessment model will be used to stratify patients according to their risk levels. All study participants will receive health education on healthy lifestyle b

Sponsors

Cancer Hospital,Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Aged 40–75 years, regardless of sex; 2. Individuals who have a definitive diagnosis of precancerous lesions with intestinal metaplasia or low-grade intraepithelial neoplasia, as confirmed by gastroscopy and histopathological examination of the gastric mucosa; 3. Individuals who agree to comply with the stratified intervention management protocol; 4. Participants who are fully informed and voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1.Individuals with endoscopic and histopathological findings before enrollment indicating high-grade intraepithelial neoplasia, gastric cancer, or esophageal lesions of high-grade or above; 2.Individuals with severe cardiovascular, cerebrovascular, respiratory, hepatic, renal, or hematopoietic system diseases, such as severe heart failure, severe asthma, or aortic aneurysm; 3.Individuals in poor physical condition who are unable to tolerate gastroscopy; 4.Individuals in the acute phase of corrosive inflammation of the upper gastrointestinal tract or with suspected perforation; 5.Pregnant women; 6.Individuals with a history of iodine allergy; 7.Individuals with severe mental illness, intellectual impairment, or language disorders who are unable to accurately describe symptoms or cooperate with the study procedures; 8.Individuals currently participating in other drug clinical trials, or those whose study adherence may be affected by severe organic diseases; 9.Individuals who have previously undergone gastric surgery, endoscopic submucosal dissection (ESD), or endoscopic mucosal resection (EMR); 10. Individuals with clinical, endoscopic, or serological evidence suggestive of autoimmune gastritis.

Design outcomes

Primary

MeasureTime frame
Cumulative incidence of gastric cancer;

Secondary

MeasureTime frame
Lesion progressive rate;The proportion of early gastric cancer cases among detected gastric cancer cases ;Lesion regression rate;Safety;compliance /feasibility;

Countries

China

Contacts

Public ContactLi Li

Cancer Hospital,Chinese Academy of Medical Sciences

lili@cicams.ac.cn+86 10 8944 5091

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Jul 23, 2026