RecruitingNot ApplicableNCT06306755

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


Sponsor

Peking University Cancer Hospital & Institute

Enrollment

21,000 participants

Start Date

Jun 25, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 50 YearsMax Age: 69 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a two-step screening approach — first a simple blood or breath test, then an endoscopy (a camera examination of the throat and stomach) — to detect esophageal and stomach cancer early in high-risk communities in China. You may be eligible if: you are a permanent resident of the study villages in Henan Province, China; you are between 50 and 69 years old; and you volunteer to participate. You may NOT be eligible if: you have had an endoscopy in the past 5 years; you have a history of cancer or mental illness; you have hepatitis B, C, or HIV; you have serious heart, lung, or digestive conditions; you are pregnant; or you have other conditions that make the exam unsafe for you. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERisk Assessment and Individualized Surveillance

1. An epidemiological questionnaire-based risk assessment for UGIC conducted prior to the endoscopic examination; 2. Individuals identified as "high-risk" receive the upper gastrointestinal endoscopic examination with Lugol's Iodine in the esophagus and indigo carmine staining in the stomach; 3. Individualized reexamination and surveillance strategy will be given to participants diagnosed with premalignant lesions, based on evaluation of risk progression using endoscopic characteristics, pathological diagnosis, and biomarkers.

PROCEDUREUniversal screening

1. A questionnaire investigation; 2. All participants undergo the upper gastrointestinal endoscopic examination with Lugol's Iodine in the esophagus and indigo carmine staining in the stomach; 3. Reexamination and surveillance will be performed according to the current guidelines for UGIC screening and clinical treatment.


Locations(1)

Department of genetics, Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, China

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NCT06306755


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