Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
Recruiting · NCT07600125 · Observational (researchers observe without assigning treatment) · Lead sponsor: Xijing Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- 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 criteria
- 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 it is running
13 locations listed.
- 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
- Qingdao Municipal Hospital - Qingdao, China
- Central Theater Command General Hospital - Wuhan, China
- Wuwei Cancer Hospital of Gansu Province - Wuwei, China
- Wuxi People's Hospital - Wuxi, China
- Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province - Zhaoqing, China
- Zhaoqing First People's Hospital, Guangdong Province - Zhaoqing, China
- The First Affiliated Hospital of Air Force Military Medical University - Xi'an, Shaanxi, China