Gut Microbiota Prediction of Metachronous Colorectal Neoplasms

Gut Microbiota Clinical Trial

Official title:

Gut Microbiota Prediction of Metachronous Colorectal Neoplasms in Patients With Colorectal Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03383159
• Other study ID #: Yunwei Wei 2017-3
• Status: Recruiting
• Start date: May 1, 2016
• Est. completion date: September 30, 2020

Study information

• Verified date: October 2017
• Source: First Affiliated Hospital of Harbin Medical University
• Contact: Yunwei Wei
• Phone: +86045185553099
• Email: hydwyw11[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Patients with colorectal cancer are known to be at high risk of developing metachronous adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's skill and the patient's bowel preparation. As life expectancy of patients with history of colon cancer is increasing, colonoscopy would increase the overall cost for patients and for the health care system. This study aim to construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis.

Description:

Colorectal cancer(CRC) is one of the most common malignancies in China and in Western countries. Furthermore, those with a history of CRC are at a higher risk for developing metachronous adenomas or CRC recurrence during the followup period. It has been reported that 0.7% of patients develop metachronous CRC during the 3 years after surgical resection for the initial CRC.

Surveillance colonoscopy is highly recommended by major international scientific societies with the intent of either detecting anastomotic recurrence at an early, curable stage or identifying metachronous premalignant(ie, adenomas) and malignant lesions. As life expectancy of patients with history of colon cancer is increasing, the costly and invasive postoperative examination increased the overall cost and suffering for patients.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While colonic microbiome development along the colorectal adenoma-carcinoma sequence. Investigators speculate that gut microbiota related to metachronous adenoma or CRC, after curative treatment.

This study aim to discover if any difference of gut microbiota exist in patients who suffer from metachronous adenomas compared with patients who do not. Further try to seek the divergence microbiota of metachronous adenomas between Proximal and Distal Colorectum. construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis. Finally, using microbita construct a predictive model of postoperative colorectal neoplasm development.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: September 30, 2020
• Est. primary completion date: May 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 75 Years

Eligibility

Inclusion Criteria:

• Requirements of informed consent and assent of participant, parent or legal guardian as applicable

• Patients who underwent exhaustive colorectal cancer surgical resection and accept colonoscopy

• Patients between the age of 35 and 75 years old without considering sex

• Patients with BMI= 18.5-23.9

• Participants can follow the visit plan

Exclusion Criteria:

• Patients with colorectal cancer with distant metastasis

• Chronic renal diseases and hepatic cirrhosis

• Chronic ischemic heart disease with unstable angina, chronic heart failure at class III or IV and acute myocardial infarction in the last 6 months

• Individuals with a history of Chronic diarrhea

• Individuals with a history of Diabetes mellitus

• Individuals with a history of Hypertension

• Individuals with a history of autoimmune diseases

• Use of antibiotics and probiotics 3 mouth before samples collection

• Individuals with a history of abdominal operation due to any reason

• Individuals with any history of cancer other than colorectal cancer

• Individuals with Inflammatory bowel disease

Related Conditions & MeSH terms

• Adenoma
• Colorectal Neoplasms
• Gut Microbiota
• Metachronous Adenoma
• Neoplasms

Locations

Country	Name	City	State
China	First affiliated hospital of Harbin medical university	Harbin	Heilongjiang

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Harbin Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences In Microbiota	The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.	1, 3 and 5 years after surgery
Secondary	Predictive model establish	Using microbita construct a predictive model of postoperative colorectal neoplasm development.	June to August of 2018
Secondary	Predictive model validation	Validation the accuracy of the predictive model.	August of 2018 to April of 2019