Colorectal Cancer Screening in Xinxiang City

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06785714

Enrollment

25000

Registered

2025-01-21

Start date

2024-09-01

Completion date

2025-01-15

Last updated

2025-01-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

45 Years to 74 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Countries

China

Outcome results