NCT06306755Recruiting
Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer
Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer: A Community-Based Randomized Controlled Trial
Source: ClinicalTrials.gov · Last updated 24 Jan 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
To evaluate the feasibility, applicability, effectiveness, and health-economic value of the risk-based sequential screening modality for esophageal and gastric cancers, the investigators aim to initiate a community-based randomized controlled trial in Xun County, Henan Province, which is a high-risk region of upper gastrointestinal cancer (UGIC) in northern China. A total of 258 target villages from all the 11 communities (townships and streets) in Xun County will be randomly selected and assigned to the sequential screening group and the universal screening group at a ratio of 2:1 and the total sample size will be 21,000. In the sequential screening group, participants in the top 50% risk level (i.e., stratified as the high-risk subgroup) will be offered a standard upper gastrointestinal endoscopic screening. In contrast, all participants in the universal screening group will receive the endoscopic examination. The surveillance strategy for participants with screening-detected premalignant lesions in the sequential screening group will be tailored based on individualized risk assessment using endoscopic characteristics, pathological diagnosis, and biomarkers. Surveillance for participants in the universal screening group will adhere to current guidelines for UGIC screening and clinical treatment. Detection rates of upper gastrointestinal malignant lesions, early-stage malignant lesions and premalignant lesions, and health-economic indicators such as the unit cost per detected malignant lesions will be compared between the two groups.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 21000 (estimated)
- First submitted
- 3 Mar 2024
- Start date
- 25 Jun 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06306755
What you commit to
- Study type: Interventional
- Planned participants: 21000
- From 25 Jun 2024 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Had a history of endoscopic examination within 5 years prior to the initial interview;
Other illness
- 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;
- In the acute phase of corrosive inflammation of the upper gastrointestinal tract, or with suspected perforation of the upper gastrointestinal tract;
- Had severe history of allergies;
- Had propensity for bleeding (coagulopathy);
Other
- 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;
- Had massive ascites, severe abdominal distension, or severe esophageal varices;
- Pregnancy;
- Others unable to tolerate the clinical examinations involved in this study.
Who the study is looking for
- 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.
Age in the registry: 50 years to 69 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of genetics, Peking University Cancer Hospital & Institute Coordinator of this site? Confirm its status | Beijing | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.