Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

Last updated: May 8, 2018
Sponsor: First Affiliated Hospital of Harbin Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Colon Cancer

Colorectal Cancer

Cancer

Treatment

N/A

Clinical Study ID

NCT03385213
Yunwei Wei 2017 -2
  • Ages 35-80
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Patients with colorectal cancer scheduled for radical coloproctectomy and between theage of 18 and 75 years old without considering sex.

  • Patients with BMI= 18.5-23.9

  • Participants can follow the visit plan

Exclusion

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 classIII 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

Study Design

Total Participants: 200
Study Start date:
May 01, 2016
Estimated Completion Date:
December 01, 2022

Study 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.

Connect with a study center

  • Yunwei Wei

    Harbin, Heilongjiang 150001
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.