Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06943768 | NOT YET RECRUITING | Gastric (Stomach) Cancer

Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test
Sponsor:

Fudan University

Information provided by (Responsible Party):

DA Intelligence XU

Brief Summary:

This is a multicenter, cross-sectional study. It is based on fecal methylation site detection, H. pylori susceptibility testing of fecal samples, and a combination of the two, compared with the "gold standard" imaging tests, CT, gastroscopy and/or pathology, for gastric cancer, benign diseases such as gastritis, and health check-ups.

Condition or disease

Gastric (Stomach) Cancer

Intervention/treatment

fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing

Detailed Description:

Primary study objective: to evaluate the sensitivity and specificity of fecal methylation site-based and fecal Helicobacter pylori gastric cancer susceptibility gene assays applied to early diagnosis and screening of gastric cancer. Secondary research objectives: 1. the accuracy, kappa value, area under the ROC curve, positive likelihood ratio, negative likelihood ratio, positive predictive value, and negative predictive value of fecal methylation site-based testing and fecal Helicobacter pylori gastric cancer susceptibility gene-based testing applied for predicting gastric cancer; 2. whether the predictive ability is significantly higher than that of conventional tumor markers, such as CA19-9, CEA, and CA72-4; and 3. the follow up of Gastritis and healthy people, to assess the cases of gastric cancer during the follow-up period and the clinical diagnosis and treatment prediction; 4. Follow-up gastric cancer patients, to assess the association with gastric cancer recurrence metastasis and treatment.

Study Type : OBSERVATIONAL
Estimated Enrollment : 3000 participants
Official Title : Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes for the Early Diagnosis and Screening of Gastric Cancer
Actual Study Start Date : 2025-06-01
Estimated Primary Completion Date : 2026-04-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Age ≥18 years, male or female.
  • * Have or will have gastroscopy and/or pathology results.
  • * 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.
Exclusion Criteria
  • * Severe cardiac, hepatic, or renal insufficiency, or psychiatric disorders.
  • * A previous history of malignant tumors of the upper gastrointestinal tract.
  • * Women during pregnancy.
  • * Those with undefined pathology.
  • * Those with unsatisfactory sample retention (e.g., too small a sample size)
Fecal DNA Methylation and Helicobacter Pylori Gastric Cancer Susceptibility Genes Test

Location Details

NCT06943768

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

No Location Found