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

NCT ID: NCT05530746

Last Updated: 2022-09-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-05-01

Study Completion Date

2023-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Colorectal Cancer Precancerous Lesion Inflammatory Bowel Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Control

Volunteers with no significant abnormalities on colonoscopy were given informed consent to obtain colon tissue biopsies and fecal specimens.

No interventions assigned to this group

Non-advanced adenoma

Patients with non-advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens.

No interventions assigned to this group

Advanced adenoma

Patients with advanced adenoma were given informed consent to obtain colon tissue biopsies and fecal specimens.

No interventions assigned to this group

Inflammatory bowel disease

Patients with inflammatory bowel disease were given informed consent to obtain colon tissue biopsies and fecal specimens.

No interventions assigned to this group

Colorectal cancer

Patients with colorectal cancer were given informed consent to obtain cancer tissue biopsies and fecal specimens.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Zhaoshen Li

Director of Gastroenterology Dept

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Zhaoshen Li, M.D

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

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Changhai Hospital, Naval Medical University

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Zhaoshen Li, M.D

Role: CONTACT

+86-021-31161365

Yu Bai, M.D

Role: CONTACT

+86-021-31161335

Facility Contacts

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Yu Bai, M.D.

Role: primary

+86-021-81873241

Yihang Song, M.D.

Role: backup

+86-021-31162770

References

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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.

Reference Type BACKGROUND
PMID: 31645732 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25104642 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33126908 (View on PubMed)

Other Identifiers

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multi-omics

Identifier Type: -

Identifier Source: org_study_id

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