Actively Recruiting
A Population-based, Multicenter Cohort Study of Combined Screening for Gastrointestinal Tumors
Led by Xijing Hospital · Updated on 2023-10-11
84000
Participants Needed
1
Research Sites
30 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a combined screening and follow-up management approach for gastrointestinal tumors. This study aims to explore and assess the feasibility and cost-effectiveness of screening for esophagus, stomach, and colorectal cancers in a population-based, multicenter setting. The trial includes participants aged 45 to 70 years and will observe outcomes over a 10-year follow-up period. Participants are divided into groups undergoing different screening methods. Group one receives gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori antigen test, RNF180 and SEPTIN9 gene methylation tests, along with an investigation of various risk factors such as past diseases, lifestyle habits, family cancer history, and reproductive status. Group two undergoes risk factor investigation, FIT, and Helicobacter pylori antigen stool test; if positive, further gene methylation tests and possibly colonoscopy are conducted. Control groups matched by spouse or sibling undergo only risk factor investigations. During the study, participants provide information on medical history, lifestyle habits, and family cancer history. Screening tests including endoscopies, stool tests, and gene methylation analyses are performed as specified. Researchers will monitor the detection of cancer or precancerous lesions over 10 years, tracking health outcomes and the effectiveness of combined screening. Safety and adherence are observed throughout the follow-up.
CONDITIONS
Brief Title
A Population-based, Multicenter Cohort Study of Combined Screening for Gastrointestinal Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects are 45 to 70 years old at enrollment
- Willing and able to sign informed consent
You will not qualify if you...
- History of any type of malignancy
- Previous resection of esophagus, stomach, or colorectal
- Received gastrointestinal endoscopy such as colonoscopy and gastroscopy in the past 5 years
- Had fecal occult blood test and fecal DNA test in the past 1 year
- Contraindications to endoscopy
- Warning symptoms of digestive tract tumors, including difficulty swallowing, choking when eating, recent foreign body sensation or swallowing pain, long-term loss of appetite, indigestion symptoms, abdominal mass or pain, vomiting or vomiting blood, medically diagnosed iron deficiency anemia, recent changes in stool color or frequency, perianal discomfort, unexplained weight loss over 10% in past 6 months
- Currently pregnant
- Serious comorbidities reducing screening benefits like severe lung, kidney, liver disease, or heart failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Initial testing period at enrollment
Participants undergo various tests including gastroscopy, colonoscopy, fecal occult blood test (FIT), Helicobacter pylori (HP) antigen test, RNF180 and SEPTIN9 gene methylation tests, and risk factor investigations based on their assigned group. Some tests are conditional based on initial results.
1 to 2 visits depending on test results
Duration - 10 years
Participants are followed for 10 years to observe outcomes such as cancer or precancerous lesions.
Periodic follow-up visits over 10 years
Trial Site Locations
Total: 1 location
1
Gaoyao District People's Hospital
Zhaoqing, Guangzhou, China, 526040
Actively Recruiting
Research Team
R
rong zheng
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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