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

NCT06306755 | Recruiting

• 1 other identifier: 2021YFC2500405
• Study Type: interventional
• Target: 21,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Esophageal Cancer; Gastric Cancer; Precision Screening; Sequential Screening; Risk Stratification

Outcome Measures

Primary Outcomes (1)

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

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

  12 months

Secondary Outcomes (12)

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

  12 months

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

  12 months

• Response rate of endoscopic examination

  12 months

• Total screening costs

  12 months

• Unit cost per detected upper gastrointestinal (esophageal/gastric) malignant lesions

  12 months

Study Arms (2)

Sequential screening group

EXPERIMENTAL

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.

Procedure: Risk Assessment and Individualized Surveillance

Universal screening group

ACTIVE COMPARATOR

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.

Procedure: Universal screening

Interventions

Risk Assessment and Individualized Surveillance PROCEDURE

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.

Sequential screening group

Universal screening PROCEDURE

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.

Universal screening group

Eligibility Criteria

• Age: 50 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Cancer Hospital & Institute: lead

Study Sites (1)

Department of genetics, Peking University Cancer Hospital & Institute

Beijing, Beijing Municipality, 100142, China

RECRUITING

Related Publications (3)

• Zheng H, Liu Z, Chen Y, Ji P, Fang Z, He Y, Guo C, Xiao P, Wang C, Yin W, Li F, Chen X, Liu M, Pan Y, Liu F, Liu Y, He Z, Ke Y. Development and external validation of a quantitative diagnostic model for malignant gastric lesions in clinical opportunistic screening: A multicenter real-world study. Chin Med J (Engl). 2024 Oct 5;137(19):2343-2350. doi: 10.1097/CM9.0000000000002903. Epub 2024 Feb 26.

  PMID: 38403900 BACKGROUND

• Liu Z, Zheng H, Liu M, He Y, Chen Y, Ji P, Fang Z, Xiao P, Li F, Guo C, Yin W, Pan Y, He Z, Ke Y. Development and External Validation of an Improved Version of the Diagnostic Model for Opportunistic Screening of Malignant Esophageal Lesions. Cancers (Basel). 2022 Nov 30;14(23):5945. doi: 10.3390/cancers14235945.

  PMID: 36497427 BACKGROUND

• He Z, Liu Z, Liu M, Guo C, Xu R, Li F, Liu A, Yang H, Shen L, Wu Q, Duan L, Li X, Zhang C, Pan Y, Cai H, Ke Y. Efficacy of endoscopic screening for esophageal cancer in China (ESECC): design and preliminary results of a population-based randomised controlled trial. Gut. 2019 Feb;68(2):198-206. doi: 10.1136/gutjnl-2017-315520. Epub 2018 Jan 6.

  PMID: 29306867 BACKGROUND

MeSH Terms

Conditions

Esophageal Neoplasms; Stomach Neoplasms

Interventions

Risk Assessment

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Digestive System Diseases; Esophageal Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Risk Management; Organization and Administration; Health Services Administration; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Central Study Contacts

Zhonghu He

CONTACT

010-88196702; zhonghuhe@bjcancer.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2024
• First Posted: March 12, 2024
• Study Start: June 25, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2034
• Last Updated: January 24, 2025

Record last verified: 2025-01

Locations

CN (1)