The Relationship Between Postoperative Changes of Oral and Intestinal Flora and Prognosis

NCT ID: NCT03667495

Last Updated: 2018-09-21

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-01

Study Completion Date

2021-03-01

Brief Summary

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Specific oral microbiome has been found to contribute to the development of colorectal cancer. We speculate that specific oral microbiota related to colorectal cancer relapse after curative treatment. This study aim to discover if any difference of oral 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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Colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide.Current estimates indicate that 20-30% of those who undergo treatment will experience recurrence and 35% of all patients will die within 5 years.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While the specific oral microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that specific oral 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 oral 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. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.

Conditions

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Gut Microbiota Oral Microbiota Colorectal Cancer

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Relapse

Patients who suffered colorectal cancer or adenoma 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 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
Minimum Eligible Age

18 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

Rui Geng

Role: CONTACT

+8613263695371

Facility Contacts

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Yunwei Wei

Role: primary

Other Identifiers

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Yunwei Wei 2018-09-04

Identifier Type: -

Identifier Source: org_study_id

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