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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05530746
Enrollment
500
Registered
2022-09-07
Start date
2022-05-01
Completion date
2023-05-31
Last updated
2022-09-07

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

Conditions

Colorectal Cancer, Inflammatory Bowel Diseases, Precancerous Lesion

Keywords

multi-omics study, adenoma, Inflammatory Bowel Disease

Brief summary

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.

Interventions

None listed

Sponsors

Changhai Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Detection of advanced colorectal adenomaThrough study completion, an average of 1 yearAn advanced colorectal adenoma is defined as a colorectal adenoma ≥10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia

Secondary

MeasureTime frameDescription
Detection of colorectal cancerThrough study completion, an average of 1 yearLesions will be confirmed as malignant by histopathologic examination.
Detection of non-advanced colorectal adenomaThrough study completion, an average of 1 yearA non-advanced colorectal adenoma is defined as tubular adenoma less than 1cm in diameter.

Countries

China

Contacts

Primary ContactZhaoshen Li, M.D
li.zhaoshen@hotmail.com+86-021-31161365
Backup ContactYu Bai, M.D
baiyu1998@hotmail.com+86-021-31161335

Outcome results

None listed

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