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

Colorectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530746
• Other study ID #: multi-omics
• Status: Recruiting
• Start date: May 1, 2022
• Est. completion date: May 31, 2023

Study information

• Verified date: September 2022
• Source: Changhai Hospital
• Contact: Zhaoshen Li, M.D
• Phone: +86-021-31161365
• Email: li.zhaoshen[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2023
• Est. primary completion date: May 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Precancerous Lesion

Locations

Country	Name	City	State
China	Changhai Hospital, Naval Medical University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Detection of advanced colorectal adenoma	An advanced colorectal adenoma is defined as a colorectal adenoma =10 mm, adenoma with tubulovillous or villous histology, or adenoma with high-grade dysplasia	Through study completion, an average of 1 year
Secondary	Detection of colorectal cancer	Lesions will be confirmed as malignant by histopathologic examination.	Through study completion, an average of 1 year
Secondary	Detection of non-advanced colorectal adenoma	A non-advanced colorectal adenoma is defined as tubular adenoma less than 1cm in diameter.	Through study completion, an average of 1 year