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Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer

ConditionsEsophageal CancerGastric CancerPrecision ScreeningSequential ScreeningRisk Stratification
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-69
SponsorPeking University Cancer Hospital & Institute

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

  • Risk Assessment and Individualized Surveillance

    Procedure/Surgery

    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.

  • Universal screening

    Procedure/Surgery

    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.

Treatment groups

21,000 Participants
are divided into 2 treatment groups
Group A: Sequential screening groupExperimental treatment 1 intervention
Group B: Universal screening groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Detection rate of upper gastrointestinal (esophageal/gastric) malignant lesions

Number of detected malignant lesions / Number of completed endoscopies × 100%

Time frame
12 months

Secondary outcomes

1

Rate of early-stage upper gastrointestinal (esophageal/gastric) malignant lesions

Time frame
12 months
2

Detection rate of upper gastrointestinal (esophageal/gastric) premalignant lesions

Time frame
12 months
3

Response rate of endoscopic examination

Time frame
12 months
4

Total screening costs

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Peking University Cancer Hospital & Institute

Lead sponsor

Source ClinicalTrials.gov
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