Analysis of Intestinal Microflora Combined With DNA Methylation in Stool to Detect Colorectal Cancer

NCT04302363 | Unknown DMC

• 1 other identifier: CCRS-2
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Introduction: Colorectal cancer (CRC) has the third highest incidence rate and the fourth mortality rate in the world. Traditional colonoscopy as an invasive examination method cannot be widely used in screening for colorectal neoplasia. The fecal immunochemical test has some limitations in sensitivity. Also, race and regional differences may affect results. Abnormality in the composition of the gut microbiota has been implicated as a potentially important etiologic factor in the initiation and progression of colorectal cancer. Analyzing fecal flora and exfoliated cell genes may represent a new screening tool for colorectal cancer.This research aims to use 16S rRNA to compare differences in fecal flora between colorectal cancer patients and healthy controls. These data combined with DNA findings of fecal exfoliated cells may further clarify this difference to build a model for screening early colorectal cancer in Chinese people. Methods and analysis: In total, 300 patients with positive colonoscopy results and 200 health controls will be recruited. All participants will complete an information form and questionnaires. Fecal samples will be examined by 16S rRNA analysis. Gene methylation levels will be detected in fecal exfoliated cells. Models of related intestinal microbiota and methylation genes will be built. Receiver operating characteristic (ROC) curve analysis will be used to select some models with appropriate sensitivity and specificity.The models will be further validated by multicenter studys.

Conditions

Gastrointestinal Microbiome; DNA Methylation; Colorectal Neoplasms

Keywords

Gastrointestinal Microbiome; DNA Methylation; Colorectal Neoplasms; Stool; biomaker

Outcome Measures

Primary Outcomes (1)

• Diagnostic efficacy of colorectal cancer model in Chinese people

  the difference in intestinal flora and gene methylation between CRC patients and healthy individuals.

  2 years

Secondary Outcomes (1)

• Effect of diet on intestinal flora and DNA methylation in Chinese people

  3 years

Other Outcomes (2)

• Effect of cholecystectomy on intestinal flora and methylation

  3 years

• Effects of intestinal microflora and DNA methylation under different stool characteristics

  3 years-4years

Study Arms (2)

Control Group

Healthy controls must be 18-75 years old with no tumors and no history of cancer.

Other: Fecal microbiota detection and exfoliated cell gene detection

Test Group

Inclusion criteria in the experimental group are age 18-75 years old, colonoscopy revealing colon or rectal tumor, biopsy-confirmed adenocarcinoma or adenoma, no chemotherapy or surgery, and no history of other cancer. Both groups must be able to understand and be willing to sign informed consent.

Other: Fecal microbiota detection and exfoliated cell gene detection

Interventions

Fecal microbiota detection and exfoliated cell gene detection OTHER

Fecal microbiota detection and exfoliated cell gene detection

Control Group; Test Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This program was performed in Xiangya Hospital(Still recruiting), Changsha, Hunan, China. Only participants who received a colonoscopy were enrolled

You may qualify if:

• colonoscopy revealing colon or rectal tumor and biopsy-confirmed adenocarcinoma or adenoma.
• no chemotherapy or surgery, and no history of other cancer.
• must be able to understand and be willing to sign informed consent.
• Healthy controls don't have tumors and history of cancer.

You may not qualify if:

• Those who not willing to provide specimens or answer questionnaires before the study began.
• People whose stool samples does not meet the requirements.
• People who are unwilling to sign written informed consent or follow a research protocol.

Sponsors & Collaborators

• WEIDONG LIU，MD: lead
• Natural Science Foundation of Hunan Province: collaborator

Study Sites (1)

Xiangya Hospital of Central South University

Changsha, Hunan, 410000, China

RECRUITING

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Biospecimen

Retention: SAMPLES WITH DNA

Fecal samples are collected from participants before colonoscopy. Participants are asked to collect stool samples in standardized containers, which are then stored at -80ºC immediately.

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• weidong Liu, PhD

  Xiangya Hospital of Central South University

  STUDY CHAIR

• mingmei Liao, PhD

  Xiangya Hospital of Central South University

  STUDY DIRECTOR

• xi Xie, PhD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• jie Chen, PhD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

• zhan Qu, PhD

  Xiangya Hospital of Central South University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

weidong Liu, PhD

CONTACT

86-13873124855; weidong.liu@csu.edu.cn

mingmei Liao, PhD

CONTACT

86-15388023797; mingmeiliao@csu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of day surgery center

Study Record Dates

• First Submitted: November 5, 2019
• First Posted: March 10, 2020
• Study Start: February 1, 2018
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2021
• Last Updated: March 10, 2020

Record last verified: 2020-03

Locations

CN (1)