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

NCT03667495 | Unknown

• 1 other identifier: Yunwei Wei 2018-09-04
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Microbiota; Oral Microbiota; Colorectal Cancer

Keywords

microbiota; colorectal cancer; recurrence

Outcome Measures

Primary Outcomes (1)

• Colorectal cancer or adenoma recurred

  Use colonoscopy to check for recurrence of colorectal cancer

  12 months after surgery

Study Arms (2)

Relapse

Patients who suffered colorectal cancer or adenoma relapse after curative surgery

Remission

Patients who get remission after curative surgery

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants were included according to the inclusion and exclusion criteria. Participants underwent an exhaustive colorectal cancer surgical resection in the First Affiliated Hospital of Harbin Medical University from September 1, 2017 to April 1, 2019. Participants did not use antibiotics and probiotics 3 mouth before samples collection.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• First Affiliated Hospital of Harbin Medical University: lead

Study Sites (1)

Yunwei Wei

Harbin, Heilongjiang, 150001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Human fecal, oral and mucosal samples for DNA extraction.

MeSH Terms

Conditions

Colorectal Neoplasms; Recurrence

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Yunwei Wei

  First Affiliated Hospital of Harbin Medical University

  STUDY DIRECTOR

Central Study Contacts

Yunwei Wei

CONTACT

+86045185553099; hydwyw11@hotmail.com

Rui Geng

CONTACT

+8613263695371; gengruihyd@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2018
• First Posted: September 12, 2018
• Study Start: November 1, 2017
• Primary Completion: November 1, 2019
• Study Completion: March 1, 2021
• Last Updated: September 21, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)