Prospective Gastric Cancer Screening Using Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection

Официальное название

Research on the Application of Fecal Helicobacter Pylori High-Risk Single Nucleotide Polymorphism Detection in the Early Diagnosis and Screening of Gastric Cancer

Обзор

This is a prospective study designed to compare the performance of fecal H. pylori gastric cancer susceptibility analysis and the gastric cancer risk questionnaire for the early detection of gastric cancer. The primary objective is to assess whether each method, individually or in combination, can facilitate earlier diagnosis of gastric cancer. All participants will undergo fecal H. pylori gastric cancer susceptibility testing and complete the gastric cancer risk questionnaire.

Подробное описание

Sample Selection:

The study will be conducted in selected communities within Tongling City, with a total of 10000-15000 residents recruited.

Participants Recruitment:

* Participation is voluntary. All subjects must provide written informed consent at the time of recruitment. * Well-trained investigators will conduct face-to-face interviews to administer the gastric cancer risk questionnaire.

Tests and Follow-up:

* Initial Screening: All participants will provide a stool sample for fecal H. pylori gastric cancer susceptibility testing and complete a questionnaire. * Definition of Screening Positive: A participant will be considered screening positive if they test positive on the H. pylori gastric cancer susceptibility testing or are identified as high-risk through the questionnaire. * Diagnostic Workup: All screening-positive individuals will be referred for a confirmatory diagnostic workup. Briefly, the endoscopist will conduct a fiberoptic endoscopy and perform a pathological biopsy. * Follow-up: Screening-positive individuals who are not diagnosed with gastric cancer in the first year will be entered into an annual follow-up program. * Biobanking: Residual fecal samples will be stored at the biobank of Fudan University Shanghai Cancer Center for future biomarker research.

Вмешательства

• Диагностический тест Fecal Helicobacter pylori gastric cancer susceptibility gene test
  In the early stage of the study, the team used genome-wide association analysis (GWAS) to identify H. pylori specific SNP that are significantly associated with gastric cancer in gastric cancer patients and controls; according to the mutation or not of the SNP loci, the strains were categorized into the high-risk group of gastric cancer and the low-risk group. The status of the SNP locus was detected in portable and non-invasive fecal samples from participants using molecular biology assays for

Первичные конечные точки

• Sensitivity and specificity of fecal H. pylori gastric cancer susceptibility testing and questionnaire for gastric cancer [Срок оценки: 2 years]

Вторичные конечные точки (3)

• Positive and negative predictive values of fecal H. pylori gastric cancer susceptibility testing and questionnaire screening for gastric cancer [Срок оценки: 2 years]
• Number needed to screen to identify one gastric cancer [Срок оценки: 2 years]
• Early diagnosis rate of gastric cancer [Срок оценки: 2 years]

Критерии участия

Критерии включения

• Age ≥40 years, male or female.
• No contraindications to endoscopy and able to cooperate with endoscopy.
• Patients must be able to fully understand the informed consent form and be able to sign the informed consent form in person.

Критерии исключения

• A history of diagnosed gastric cancer or other malignant tumors of the digestive tract.
• Comorbid severe underlying conditions (e.g., severe cardiopulmonary insufficiency, liver or renal failure, etc.) that are likely to result in a short life expectancy or render long-term follow-up impractical.
• Severe mental illness or incapacity to participate in the study due to lack of civil behavior.
• Pregnant or breastfeeding women.
• Other conditions that the investigator deems inappropriate for participation in the study.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• People's Hospital of Tongling City — Tongling

Идентификаторы

NCT: NCT06943781 · 2410-Exp081

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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