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NCT Number: NCT07769892

A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers

This project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract endoscopy are enrolled. Blood and stool samples are collected prior to endoscopic examination for detection of blood multi-gene methylation, fecal immunochemical test (FIT) and calprotectin. Endoscopic procedures are then performed. Following completion of baseline endoscopic screening, all enrolled participants will be followed up for 5 years. The primary endpoint of this study is the sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for pan-digestive tract cancers.

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Key information

Conditions

Gastrointestinal Cancers Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province, Zhaoqing, Guangdong, China

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.

Exclusion criteria

  • 1. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.

Treatment and study plan

Primary outcomes

  1. Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard

    Time frame: Day 1 At endoscopy and pathological confirmation after enrollment

  2. Specificity of combined biomarkers for pan-digestive tract cancer screening

    Time frame: Day 1 At endoscopy and pathological confirmation after enrollment

Secondary outcomes

  1. Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.

    Time frame: 5 years after enrollment

  2. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening

    Time frame: 5 years after enrollment

  3. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening

    Time frame: 5 years after enrollment

  4. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening

    Time frame: 5 years after enrollment

  5. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer

    Time frame: 5 years after enrollment

  6. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer

    Time frame: 5 years after enrollment

  7. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer

    Time frame: 5 years after enrollment

  8. Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality.

    Time frame: 5 years after enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Rong Zheng

CONTACT

[email protected]

+86 198 2975 8242

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

A Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers

Important dates

Study start
2026
Primary completion
2035
Study completion
2035
First posted
Aug 18, 2026
Registry last updated
Aug 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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