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).

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 25000

Contacts and Locations

Study Locations

• China
  • Henan
    • Xinxiang, Henan, China, 453100
      • The First Affiliated Hospital of Xinxiang Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.

Description

Inclusion Criteria:

1. Subjects aged 45-74 years at time of consent
2. Have not had gastrointestinal resection

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity of colorectal cancer detection	Sensitivity of colorectal cancer detection	180 days
Specificity of advanced neoplasia detection	Specificity of advanced neoplasia detection	180 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Positive predictive value of colorectal cancer detection	Positive predictive value of colorectal cancer detection	180 days
Negative predictive value of colorectal cancer detection	Negative predictive value of colorectal cancer detection	180 days
Sensitivity and specificity of advanced adenoma detection	Sensitivity and specificity of advanced adenoma detection	180 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Actual): January 15, 2025
• Study Completion (Actual): January 15, 2025

Study Registration Dates

• First Submitted: January 15, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 15, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Colorectal Neoplasms
• Other Study ID Numbers: Chase 008

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No