Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC

Naval Military Medical University

Status: Enrolling

Conditions: Inflammatory Bowel Diseases; Precancerous Lesion; Colorectal Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT05530746

multi-omics

Details and patient eligibility

About

Colorectal cancer (CRC) has become one of the most common malignant tumors in the world, and the key to its prevention and control is early detection and treatment. As colorectal adenoma and inflammatory bowel disease (IBD) are the inevitable precursors of most CRC, screening for colorectal adenoma and IBD is of great importance for preventing CRC. The existing detection methods have high sensitivity for CRC, while limited in colorectal adenoma and IBD. Therefore, exploring a detection method with high sensitivity for colorectal adenoma and IBD is necessary. This project intends to use methylation detection technology, lactic acid modified omics, proteomics, metagenomics, and other omics technology, through the analysis of differences in feces and histological results in healthy volunteers, patients with non-advanced adenoma, patients with advanced adenomas, patients with IBD, and patients with CRC for early screening.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients whose age is between 18-75.
• Patients who have signed informed consent form.

Exclusion criteria

• Patients who have undergone colonic resection or polypectomy.
• Patients with abnormal blood coagulation or taking antiplatelets or anticoagulants within 7 days.
• Patients with hereditary colorectal cancer syndrome (including familial adenomatous polyposis).
• Patients with pregnancy, severe chronic cardiopulmonary and renal disease.
• Patients with failed cecal intubation.
• Patients with poor BPQ necessitated a second bowel preparation.
• Patients refusing to participate or to provide informed consent

Trial design

500 participants in 5 patient groups

Control

Description:

Volunteers with no significant abnormalities on colonoscopy were given informed consent to obtain colon tissue biopsies and fecal specimens.

Non-advanced adenoma

Description:

Patients with non-advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens.

Advanced adenoma

Description:

Patients with advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens.

Inflammatory bowel disease

Description:

Patients with inflammatory bowel disease were given informed consent to obtain colon tissue biopsies and fecal specimens.

Colorectal cancer

Description:

Patients with colorectal cancer were given informed consent to obtain cancer tissue biopsies and fecal specimens.