Effectiveness of Risk-based Sequential Screening for Esophageal and Gastric Cancer: A Community-Based Randomized Controlled Trial

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 69
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
Department of genetics, Peking University Cancer Hospital & Institute
RECRUITING
Beijing
Contact Information
Primary
Zhonghu He
zhonghuhe@bjcancer.org
010-88196702
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2034-12
Participants
Target number of participants: 21000
Treatments
Experimental: Sequential screening group
The enrolled participants will undergo a questionnaire investigation and receive a risk assessment for esophageal and gastric malignancies based on two questionnaire-based diagnostic models. Participants identified as high-risk (i.e., with a top 50% risk level) for esophageal and/or gastric malignancy will receive the standard upper gastrointestinal endoscopy. Standardized diagnosis and treatment recommendations will be provided to patients with screening-detected malignant lesions, and green referral channels will be established for them. For participants with screening-detected premalignant lesions, the risk of progression will be evaluated based on endoscopic characteristics, pathological diagnosis, and biomarkers. Individualized reexamination and surveillance will be implemented accordingly.
Active_comparator: Universal screening group
The enrolled participants will undergo a questionnaire investigation and receive the same standard upper gastrointestinal endoscopy as those in the sequential screening group, irrespective of the results of the risk assessment. Standardized diagnosis and treatment recommendations will be provided to patients with screening-detected malignant lesions, and green referral channels will be established for them. For participants with screening-detected premalignant lesions, the reexamination and surveillance will be performed according to the current guidelines for UGIC screening and clinical treatment.
Related Therapeutic Areas
Sponsors
Leads: Peking University Cancer Hospital & Institute

This content was sourced from clinicaltrials.gov

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