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

H

Harbin Medical University

Status

Unknown

Conditions

Oral Microbiota
Gut Microbiota
Colorectal Cancer

Study type

Observational

Funder types

Other

Identifiers

NCT03667495
Yunwei Wei 2018-09-04

Details and patient eligibility

About

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.

Full description

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.

Enrollment

100 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

100 participants in 2 patient groups

Relapse
Description:
Patients who suffered colorectal cancer or adenoma relapse after curative surgery
Remission
Description:
Patients who get remission after curative surgery

Trial contacts and locations

1

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Central trial contact

Rui Geng; Yunwei Wei

Data sourced from clinicaltrials.gov

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