Clinical trial NCT05530746: Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC
Official title: Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of Colorectal Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer
Precancerous Lesion
Inflammatory Bowel Diseases
Keywords: multi-omics study
adenoma
Inflammatory Bowel Disease
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2022-09-07
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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.


Eligibility 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

Primary outcomes:
measure: Detection of advanced colorectal adenoma
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Detection of colorectal cancer
timeFrame: Through study completion, an average of 1 year
measure: Detection of non-advanced colorectal adenoma
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
Study officials:
affiliation: Study Principal Investigator
name: Zhaoshen Li, M.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zhang D, Tang Z, Huang H, Zhou G, Cui C, Weng Y, Liu W, Kim S, Lee S, Perez-Neut M, Ding J, Czyz D, Hu R, Ye Z, He M, Zheng YG, Shuman HA, Dai L, Ren B, Roeder RG, Becker L, Zhao Y. Metabolic regulation of gene expression by histone lactylation. Nature. 2019 Oct;574(7779):575-580. doi: 10.1038/s41586-019-1678-1. Epub 2019 Oct 23.
citation: Zackular JP, Rogers MA, Ruffin MT 4th, Schloss PD. The human gut microbiome as a screening tool for colorectal cancer. Cancer Prev Res (Phila). 2014 Nov;7(11):1112-21. doi: 10.1158/1940-6207.CAPR-14-0129. Epub 2014 Aug 7.
citation: Wang J, Liu S, Wang H, Zheng L, Zhou C, Li G, Huang R, Wang H, Li C, Fan X, Fu X, Wang X, Guo H, Guan J, Sun Y, Song X, Li Z, Mu D, Sun J, Liu X, Qi Y, Niu F, Chen C, Wu X, Wang X, Song X, Zou H. Robust performance of a novel stool DNA test of methylated SDC2 for colorectal cancer detection: a multicenter clinical study. Clin Epigenetics. 2020 Oct 30;12(1):162. doi: 10.1186/s13148-020-00954-x.