Evaluating a new screening method for esophageal and gastric cancer
Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer: A Community-Based Randomized Controlled Trial
This study is trying out a new way to screen for esophageal and gastric cancer in people aged 50 to 69 in northern China to see if focusing on high-risk individuals improves detection rates.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 21000 (estimated) |
| Ages | 50 Years to 69 Years |
| Sex | All |
| Sponsor | Peking University Cancer Hospital & Institute Academic / other |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT06306755 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the feasibility and effectiveness of a risk-based sequential screening approach for esophageal and gastric cancers in a high-risk region of northern China. Participants aged 50 to 69 from selected villages in Xun County will be randomly assigned to either a sequential screening group, where only high-risk individuals receive endoscopic screening, or a universal screening group, where all participants undergo screening. The goal is to improve detection rates of upper gastrointestinal malignant lesions while optimizing resource use. The study will involve approximately 21,000 participants and aims to demonstrate the health-economic value of this targeted screening strategy.
Who should consider this trial
Good fit: Ideal candidates are residents of Xun County, Henan Province, aged 50 to 69 who can provide informed consent.
Not a fit: Patients with a history of cancer, severe health conditions, or those who have undergone endoscopic examination in the past five years may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier detection of esophageal and gastric cancers, improving patient outcomes and potentially saving lives.
How similar studies have performed: Previous studies have indicated that targeted screening approaches can improve detection rates, suggesting potential success for this novel method.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Permanent residency in the target villages in Xun County, Henan Province, China; * Aged 50 to 69 at the enrollment; * Voluntarily participate in this study and provide informed consent. Exclusion Criteria: * Had a history of endoscopic examination within 5 years prior to the initial interview; * Had a history of cancer; * Had a history of mental disorder; * Positive for hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus (HIV); * Had severe cardiovascular and cerebrovascular diseases; * Had severe respiratory disease, dyspnea, or asthmaticus status; * Had retropharyngeal abscess, severe spinal deformity, or aortic aneurysm; * With physical debility unable to tolerate endoscopic examination, or with difficulty in achieving sedation and self-control; * In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or with suspected perforation of the upper gastrointestinal tract; * Had massive ascites, severe abdominal distension, or severe esophageal varices; * Pregnancy; * Had severe history of allergies; * Had propensity for bleeding (coagulopathy); * Others unable to tolerate the clinical examinations involved in this study.
Where this trial is running
Beijing, Beijing Municipality
- Department of genetics, Peking University Cancer Hospital & Institute — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhonghu He
- Email: zhonghuhe@bjcancer.org
- Phone: 010-88196702
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.