What is this study trying to find out about digestive diseases?

This study is evaluating a combined screening approach for gastrointestinal tumors including esophagus, stomach, and colorectal cancers. Researchers want to see how feasible and cost-effective this combined screening is for detecting cancer early. The study is sponsored by Xijing Hospital and involves long-term monitoring of participants' health outcomes.

Who may be eligible for this digestive disease clinical trial?

Adults aged 45 to 70 years who are willing to participate and can provide informed consent may be eligible. Participants should not have a history of any cancer, prior gastrointestinal surgeries, or recent relevant screenings. Both men and women can join. Please review eligibility criteria for more details.

Is there any cost to participate in this digestive disease clinical trial?

Study-related care, including all screening tests and trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants should plan accordingly when considering joining the trial.

Actively Recruiting

Age: 45Years - 70Years

All Genders

Healthy Volunteers

ID05996458

Combined Screening and Follow-Up Study for Gastrointestinal Tumors in Adults Aged 45 to 70

Led by Xijing Hospital · Updated on 2023-10-11

84000

Participants Needed

Research Sites

30 weeks

Total Duration

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

Age: 45Years - 70Years

All Genders

Healthy Volunteers

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

Research Team

rong zheng

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