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Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study

Status: Recruiting
Location: See all (13) locations...
Intervention Type: Diagnostic test
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
The First Affiliated Hospital of Dalian Medical University
RECRUITING
Dalian
Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
RECRUITING
Hami
Cao County People's Hospital
RECRUITING
Heze
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
RECRUITING
Jinan
PetroChina Central Hospital, Hebei
RECRUITING
Langfang
Huoqiu County People's Hospital
RECRUITING
Liu‘an
Qingdao Municipal Hospital
RECRUITING
Qingdao
Central Theater Command General Hospital
RECRUITING
Wuhan
Wuwei Cancer Hospital of Gansu Province
RECRUITING
Wuwei
Wuxi People's Hospital
RECRUITING
Wuxi
The First Affiliated Hospital of Air Force Military Medical University
RECRUITING
Xi'an
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
RECRUITING
Zhaoqing
Zhaoqing First People's Hospital, Guangdong Province
RECRUITING
Zhaoqing
Contact Information
Primary
Zheng
zhengrong4956@163.com
+86 198 2975 8242
Time Frame
Start Date: 2026-08-10
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 5000
Sponsors
Leads: Xijing Hospital

This content was sourced from clinicaltrials.gov