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Fecal Immunochemical Test for Advanced Adenoma Detection in Colorectal Cancer Screening

S

Shandong University

Status

Unknown

Conditions

Colorectal Adenoma
Colorectal Neoplasms
Colorectal Cancer

Treatments

Diagnostic Test: Fecal Immunochemical Test

Study type

Observational

Funder types

Other

Identifiers

NCT05200611
2022SDU-QILU-103

Details and patient eligibility

About

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.

Full 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.

Enrollment

5,000 estimated patients

Sex

All

Ages

50 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

5,000 participants in 1 patient group

Fecal Immunochemical Test
Description:
People in this group with positive fecal immunochemical test results were further examined by colonoscopy.
Treatment:
Diagnostic Test: Fecal Immunochemical Test

Trial contacts and locations

2

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Central trial contact

Ruchen Zhou; Yanqing Li

Data sourced from clinicaltrials.gov

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