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

September 5, 2022 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital, Naval Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of advanced colorectal adenoma
Time Frame: Through study completion, an average of 1 year
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Detection of colorectal cancer
Time Frame: Through study completion, an average of 1 year
Lesions will be confirmed as malignant by histopathologic examination.
Through study completion, an average of 1 year
Detection of non-advanced colorectal adenoma
Time Frame: Through study completion, an average of 1 year
A non-advanced colorectal adenoma is defined as tubular adenoma less than 1cm in diameter.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Principal Investigator: Zhaoshen Li, M.D, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

May 31, 2023

Study Completion (Anticipated)

May 31, 2023

Study Registration Dates

First Submitted

September 1, 2022

First Submitted That Met QC Criteria

September 5, 2022

First Posted (Actual)

September 7, 2022

Study Record Updates

Last Update Posted (Actual)

September 7, 2022

Last Update Submitted That Met QC Criteria

September 5, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • multi-omics

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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