Trial Title:
A Population-based, Multicenter Cohort Study of Combined Screening for Gastrointestinal Tumors
NCT ID:
NCT05996458
Condition:
Digestive Disease
Conditions: Official terms:
Digestive System Neoplasms
Gastrointestinal Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
Intervention:
Intervention type:
Other
Intervention name:
Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
Description:
group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult
blood test (FIT), Helicobacter pylori (HP) antigen test, RNF180/Septin9 gene methylation
test, and investigation of risk factors, including past disease history, alcohol drinking
history, smoking history, tea drinking history, family history of cancer, marital and
reproductive status, and dietary habits.
Arm group label:
group one
Intervention type:
Other
Intervention name:
Risk factor investigation;
Description:
Only the risk factors will be investigated, including previous disease history, drinking
history, smoking history, drinking history, family history of malignant tumor, marriage
and childbearing status, eating habits, etc.
Arm group label:
Group one's control（Spouse or sibling of group one )
Arm group label:
group two's control（Spouse or sibling of group two)
Intervention type:
Other
Intervention name:
Gastroenteroscopy；Risk factor investigation; FIT-HP;RNF180 and SEPTIN9 gene methylation test
Description:
group two: The screening population will undergo investigation of risk factors, a fecal
occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a
stool occult blood test or H. pylori antigen is positive after testing, RNF180 and
SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is
positive, a colonoscopy will be scheduled.
Arm group label:
group two
Summary:
To establish combined gastroenteroscopy screening and follow-up management for
gastrointestinal tumors, explore and evaluate the feasibility and health economic
benefits of combined screening for esophagus, stomach and colorectal cancer
Detailed description:
group one: The screening population will undergo gastroscopy, colonoscopy, fecal occult
blood test (FIT), Helicobacter pylori (HP) antigen test, ring finger protein 180 (RNF180)
and SEPTIN9 gene methylation test, and investigation of risk factors, including past
disease history, alcohol drinking history, smoking history, tea drinking history, family
history of cancer, marital and reproductive status, and dietary habits.
group two: The screening population will undergo investigation of risk factors, a fecal
occult blood test (FIT), and a stool test for Helicobacter pylori (HP) antigen. If a
stool occult blood test or H. pylori antigen is positive after testing, RNF180 and
SEPTIN9 gene methylation testing will be scheduled. If the gene methylation test is
positive, a colonoscopy will be scheduled.
Group one's control（Spouse or sibling of group one);group two's control（Spouse or sibling
of group one): Only the risk factors will be investigated, including previous disease
history, drinking history, smoking history, drinking history, family history of malignant
tumor, marriage and childbearing status, eating habits, etc.
Finally, 10 years follow-up will be conducted to observe the outcome
Criteria for eligibility:
Study pop:
Eligible Chinese persons
Sampling method:
Probability Sample
Criteria:
Inclusion Criteria:
-
1. Subjects were 45 to 70 years old when enrolled 2. Willing and able to sign
informed consent
Exclusion Criteria:
-
1. History of any type of malignancy 2. Previous resection of esophagus, stomach
or colorectal 3. Received gastrointestinal endoscopy such as colonoscopy and
gastroscopy in recent 5 years 4. Have received fecal occult blood test and
fecal DNA test in the past 1 year. 5. Contraindications to endoscopy. 6.
Warning symptoms of digestive tract tumors, including:
1. Difficulty swallowing, choking or halting feeling when eating recently
2. Recent esophageal foreign body sensation or swallowing pain
3. Recent long-term loss of appetite and appetite
4. Recent and prolonged symptoms of indigestion (including acid reflux, heartburn,
abdominal grumbling, burping, nausea or premature satiety, etc.)
5. Recent symptoms of abdominal mass, abdominal pain, vomiting or hematemesis
6. It was medically diagnosed as iron deficiency anemia
7. Recent changes in hematochezia, black stool or stool character and frequency
8. Recent symptoms of perianal discomfort (including soreness, itching, lumps,
prolapse or other discomfort)
9. Unexplained weight loss (more than 10% of base body weight) in the past 6
months Step 7 Get pregnant 8. There are other serious comorbiditions that
reduce screening benefits (including severe lung disease, advanced kidney
disease, advanced liver disease, severe heart failure, etc.)
Gender:
All
Minimum age:
45 Years
Maximum age:
70 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Gaoyao District People's Hospital
Address:
City:
Zhaoqing
Zip:
526040
Country:
China
Status:
Recruiting
Contact:
Last name:
xianchun gao, doctor
Phone:
18165302960
Email:
gigaoxc@163.com
Start date:
August 1, 2023
Completion date:
June 30, 2033
Lead sponsor:
Agency:
Xijing Hospital
Agency class:
Other
Source:
Xijing Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05996458
