Study on the Diagnostic Value of Multi-omics Combined Detection for Precancerous Lesions of CRC
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2022
CompletedFirst Submitted
Initial submission to the registry
September 1, 2022
CompletedFirst Posted
Study publicly available on registry
September 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
May 31, 2023
CompletedSeptember 7, 2022
September 1, 2022
1.1 years
September 1, 2022
September 5, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Detection of colorectal cancer
Through study completion, an average of 1 year
Detection of non-advanced colorectal adenoma
Through study completion, an average of 1 year
Study Arms (5)
Control
Volunteers with no significant abnormalities on colonoscopy were given informed consent to obtain colon tissue biopsies and fecal specimens.
Non-advanced adenoma
Patients with non-advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens.
Advanced adenoma
Patients with advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens.
Inflammatory bowel disease
Patients with inflammatory bowel disease were given informed consent to obtain colon tissue biopsies and fecal specimens.
Colorectal cancer
Patients with colorectal cancer were given informed consent to obtain cancer tissue biopsies and fecal specimens.
Eligibility Criteria
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.
You may qualify if:
- Patients whose age is between 18-75.
- Patients who have signed informed consent form.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Changhai Hospital, Naval Medical University
Shanghai, 200433, China
Related Publications (3)
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.
PMID: 31645732BACKGROUNDZackular 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.
PMID: 25104642BACKGROUNDWang 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.
PMID: 33126908BACKGROUND
Biospecimen
Feces and colon histological specimens will be obtained in healthy individuals, patients with non-advanced adenoma, patients with advanced adenomas, patients with Inflammatory bowel disease, and patients with colon cancer.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Zhaoshen Li, M.D
Study Principal Investigator
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Gastroenterology Dept
Study Record Dates
First Submitted
September 1, 2022
First Posted
September 7, 2022
Study Start
May 1, 2022
Primary Completion
May 31, 2023
Study Completion
May 31, 2023
Last Updated
September 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share