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Trial Title:
Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC
NCT ID:
NCT05530746
Condition:
Colorectal Cancer
Precancerous Lesion
Inflammatory Bowel Diseases
Conditions: Official terms:
Colorectal Neoplasms
Intestinal Diseases
Inflammatory Bowel Diseases
Conditions: Keywords:
multi-omics study
adenoma
Inflammatory Bowel Disease
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Cross-Sectional
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.
Criteria for eligibility:
Study pop:
The study population was derived from patients at the Gastroenterology Endoscopy Center
of Changhai Hospital in Shanghai, China. And the subjects were divided into five groups
according to clinical and histopathological characteristics.
Sampling method:
Probability Sample
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Changhai Hospital, Naval Medical University
Address:
City:
Shanghai
Zip:
200433
Country:
China
Status:
Recruiting
Contact:
Last name:
Yu Bai, M.D.
Phone:
+86-021-81873241
Email:
baiyu1998@hotmail.com
Contact backup:
Last name:
Yihang Song, M.D.
Phone:
+86-021-31162770
Email:
noah_ir77@163.com
Start date:
May 1, 2022
Completion date:
May 31, 2023
Lead sponsor:
Agency:
Changhai Hospital
Agency class:
Other
Source:
Changhai Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05530746
