Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
About this study
This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.
- Condition
- Gastric Cancer, Colorectal Cancer
- Tested
- Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkers
- Sponsor
- Xijing Hospital
Who can join
- Age
- 18 years and older
- Sex
- All sexes
- Healthy volunteers
- Accepted
Inclusion 6
- Minimum age: 18 years
- Study condition: Gastric Cancer, Colorectal Cancer
- Participants must be at least 18 years of age at the time of enrollment;
- Participants must be scheduled to undergo gastroscopy and colonoscopy;
- Participants must agree to undergo a two-year follow-up as outlined in the protocol;
- Participants must be willing to participate and sign an informed consent form.
Exclusion 5
- Have undergone gastrointestinal endoscopy screening within the past year;
- History of any type of gastrointestinal malignancy;
- Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;
- Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);
- Pregnant or breastfeeding women.
Where
13 sites, 13 recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian, China
Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
Hami, China
Cao County People's Hospital
Heze, China
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan, China
PetroChina Central Hospital, Hebei
Langfang, China
Huoqiu County People's Hospital
Liu‘an, China
and 7 more sites on ClinicalTrials.gov
Contact
-
Zheng
+86 198 2975 8242 zhengrong4956@163.com
Potential match only. Final eligibility is determined by the study team.