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Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening

Application of Fecal Immunochemical Test for Improving Advanced Adenoma Detection in Colorectal Cancer Screening

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05200611
Enrollment
5000
Registered
2022-01-21
Start date
2022-01-04
Completion date
2022-07-01
Last updated
2022-01-21

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

Conditions

Colorectal Cancer, Colorectal Neoplasms, Colorectal Adenoma

Keywords

Colorectal Adenoma, Occult Bleeding, Quantitative fecal immunochemical test

Brief summary

Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Detailed description

Colorectal cancer accounts for approximately 10% of all annually diagnosed cancers and cancer-related deaths worldwide. With progress of developing countries, it is predicted that the incidence of colorectal cancer worldwide will increase to 2.5 million new cases in 2035. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. In order to reduce the incidence of colorectal cancer, improve the early diagnosis of colorectal cancer, the investigators conducted this study to explore diagnostic accuracy of fecal immunochemical test in colorectal cancer screening population.

Interventions

Participants with positive fecal immunochemical test results were further examined by colonoscopy.

Sponsors

The People's Hospital of Zhaoyuan City
CollaboratorUNKNOWN
Shanghe People's Hospital
CollaboratorUNKNOWN
Shandong University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
50 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

* Adults 50-75 years old

Exclusion criteria

* People with history of intestinal surgery; * People with history of colorectal cancer; * People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding; * People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea; * Pregnancy, lactation or menstrual phase; * Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.

Design outcomes

Primary

MeasureTime frameDescription
The efficacy of fecal immunochemical test to detect advanced adenoma6 monthsThe detection rate and positive predictive value of fecal immunochemical test to detect advanced adenoma

Secondary

MeasureTime frameDescription
The efficacy of fecal immunochemical test to detect colorectal cancer6 monthThe detection rate and positive predictive value of fecal immunochemical test to detect colorectal cancer
The efficacy of fecal immunochemical test to detect colorectal neoplasms6 monthThe detection rate and positive predictive value of fecal immunochemical test to detect colorectal neoplasms

Countries

China

Contacts

Primary ContactRuchen Zhou
sdlwzrc@126.com+8615949702165
Backup ContactYanqing Li
liyanqing@sdu.edu.cn+8618560087666

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026