A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model

Официальное название

A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model: A Multi-center Prospective Randomized Controlled Trial

Обзор

This study is a multicenter, randomized controlled trial. The plan is to enroll eligible participants and randomly assign them to two groups: one group will undergo testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calpetin"; those with positive results will immediately undergo standard gastrointestinal endoscopy, while those with negative results will enter routine observation; the other group will undergo only routine observation and follow-up. All enrolled participants will undergo a 5-year prospective follow-up, during which information on gastrointestinal cancer incidence and mortality will be collected through regular contact and review of medical records. The primary endpoint of the study is the difference in 5-year all-gastrointestinal cancer mortality between the two groups.This project aims to use a randomized controlled trial design to evaluate whether an active screening strategy based on a combined model can effectively reduce the population-level mortality from gastrointestinal cancers compared to routine surveillance. The objective is to provide high-level evidence for establishing a new screening strategy that reduces the disease burden and delivers public health benefits. It lays the foundation for validating novel biomarkers and exploring the biological and behavioral factors that influence screening outcomes, and offers clear decision-making support for optimizing China's comprehensive prevention and control system for gastrointestinal cancers.

Вмешательства

• Диагностический тест Multi-target blood methylation + fecal FIT + fecal calprotectin
  The intervention group underwent testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calprotectin"; those with positive results subsequently underwent standard gastrointestinal endoscopy, while those with negative results were placed under routine observation.

Первичные конечные точки

• Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups. [Срок оценки: Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.]

Вторичные конечные точки (5)

• The incidence of gastrointestinal cancer in the two groups [Срок оценки: Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment]
• Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group [Срок оценки: Baseline]
• All-cause mortality in the two groups [Срок оценки: All-cause mortality among all participants within 5 years of enrollment]
• Detection rate of precancerous lesions and early-stage gastrointestinal tumors [Срок оценки: At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment]
• Incidence of endoscopy-related complications [Срок оценки: Incidence of various endoscopy-related complications observed within 5 years]

Критерии участия

Критерии включения

• Participants must be between 45 and 74 years of age at the time of enrollment;
• Participants must agree to be randomly assigned to different screening and follow-up strategies;
• Participants must agree to undergo a five-year follow-up in accordance with the protocol;
• Participants must be willing to participate and sign an informed consent form.

Критерии исключения

• Underwent upper gastrointestinal endoscopy screening within the past year;
• History of any type of malignant tumor;
• Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;
• Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);
• Pregnant or breastfeeding women.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Скрининг

Центры проведения

Китай · 6 центров

• Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province — Zhaoqing
• The 960th Hospital of the Joint Support Force of the People's Liberation Army of China — Цзинань
• Yanting County Tumor Hospital — Mianyang
• Wuwei Cancer Hospital of Gansu Province — Wuwei
• Wuxi People's Hospital — Wuxi
• Zhaoqing First People's Hospital, Guangdong Province — Zhaoqing

Идентификаторы

NCT: NCT07712107 · KY20262032-C-1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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