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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03385213
Other study ID # Yunwei Wei 2017 -2
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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