Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

Colorectal Cancer Clinical Trial

Official title:

Structural of the Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapses After Curative Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03385213
• Other study ID #: Yunwei Wei 2017 -2
• Status: Recruiting
• Start date: May 1, 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: December 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

Colonic microbiome has been found to contribute to the development of colorectal cancer. We speculate that gut microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of gut microbiota exist in patients who suffer from cancer relapse compared with patients who do not. Finally develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Description:

Treatments for colorectal cancer of all stages have evolved considerably over the past two decades, resulting in improved long-term outcomes. After curative treatment, however, 30% of patients with stage I-III and up to 65% of patients with stage IV colorectal cancer develop recurrent disease.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While the colonic microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that gut microbiota related to colorectal cancer relapse after curative treatment.

Patients are routinely offered surveillance in order to detect disease recurrence at an early, asymptomatic stage, with the intention of improving survival. Nevertheless, controversy continues to surround the optimal surveillance protocols. Investigators aim to discover if any difference of gut microbiota is exist in patients who suffer from relapse compared with patients who do not.

Future surveillance after colorectal cancer treatment should focus on risk-stratification and should incorporate current knowledge on risk of recurrence in relation to the biology of the tumour as well as gut microbiota feature. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

Inclusion Criteria:

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

• Patients with colorectal cancer scheduled for radical coloproctectomy and between the age of 18 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

• Colorectal Cancer
• Colorectal Neoplasms
• Gut Microbiota
• Recurrence

Locations

Country	Name	City	State
China	Yunwei Wei	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	Transcriptional changes in gut microbiota	16S rRNA gene sequencing will be performed with stander procedure	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery
Secondary	Epigenetic changes	DNA methylation levels are analysed at baseline and after probiotics use in tissue samples	Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery