Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

NCT ID: NCT03385213

Last Updated: 2018-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2022-12-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Gut Microbiota Colorectal Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Relapse

Patients who suffered colorectal cancer relapse after curative surgery

No interventions assigned to this group

Remission

Patients who get remission after curative surgery

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

35 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Harbin Medical University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yunwei Wei

Role: STUDY_DIRECTOR

First Affiliated Hospital of Harbin Medical University

Locations

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Yunwei Wei

Harbin, Heilongjiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yunwei Wei

Role: CONTACT

+86045185553099

Yang Liu

Role: CONTACT

+8618345180169

Facility Contacts

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Yunwei Wei

Role: primary

Other Identifiers

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Yunwei Wei 2017 -2

Identifier Type: -

Identifier Source: org_study_id

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