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OpenTrials
Completed

NCT Number: NCT06785714

Colorectal Cancer Screening in Xinxiang City

The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).

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Key information

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First Affiliated Hospital of Xinxiang Medical University

Xinxiang, Henan, 453100, China

About this study

The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Subjects aged 45-74 years at time of consent
  • Have not had gastrointestinal resection

Exclusion criteria

  • Previous history of colorectal cancer
  • Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
  • Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
  • Those with severe mental disorders and language communication disorders
  • History of contraindications to colonoscopy
  • Pregnant women

Treatment and study plan

Primary outcomes

  1. Sensitivity of colorectal cancer detection

    Time frame: 180 days

    Sensitivity of colorectal cancer detection

  2. Specificity of advanced neoplasia detection

    Time frame: 180 days

    Specificity of advanced neoplasia detection

Secondary outcomes

  1. Positive predictive value of colorectal cancer detection

    Time frame: 180 days

    Positive predictive value of colorectal cancer detection

  2. Negative predictive value of colorectal cancer detection

    Time frame: 180 days

    Negative predictive value of colorectal cancer detection

  3. Sensitivity and specificity of advanced adenoma detection

    Time frame: 180 days

    Sensitivity and specificity of advanced adenoma detection

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xinxiang Medical College

Other

Collaborators

  • Shanghai Jiao Tong University School of Medicine
  • The Affiliated People's Hospital of Xinxiang Medical University
  • The Third Affiliated Hospital of Xinxiang Medical College
  • Xinjiang Center for Disease Control and Prevention
  • Xinxiang Central Hospital
  • Xinxiang Municipal Health Commission

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 21, 2025
Registry last updated
Jan 21, 2025

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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