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NCT Number: NCT07600125

Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers

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 FIT, quantitative 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Qualitative FIT, quantitative FIT, and testing for new biomarkers

Diagnostic Test

Stool samples are collected from participants before endoscopy for qualitative FIT, quantitative FIT, and novel biomarker testing. The results are used to screen for gastrointestinal cancers.

Primary outcomes

  1. Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening

    Time frame: At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.

Study contacts

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

Sponsors and collaborators

Lead sponsor

Xijing Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 20, 2026
Registry last updated
May 20, 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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