Gut Microbiota Prediction of Metachronous Colorectal Neoplasms

NCT03383159 | Unknown

• 1 other identifier: Yunwei Wei 2017-3
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with colorectal cancer are known to be at high risk of developing metachronous adenoma, however, participation in colonoscopy are low. Colonoscopy, the primary modality used all over the word, is costly and invasive, and its efficacy depends on the endoscopist's skill and the patient's bowel preparation. As life expectancy of patients with history of colon cancer is increasing, colonoscopy would increase the overall cost for patients and for the health care system. This study aim to construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis.

Conditions

Gut Microbiota; Metachronous Adenoma

Keywords

Microbiota; Metachronous Adenoma; Colorectal Cancer; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Differences In Microbiota

  The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.

  1, 3 and 5 years after surgery

Secondary Outcomes (2)

• Predictive model establish

  June to August of 2018

• Predictive model validation

  August of 2018 to April of 2019

Study Arms (4)

Observation group 1

Patients who suffered metachronous adenoma after proximal colorectum cancer surgery.

Control group 1

Patients who do not suffere metachronous adenoma after proximal colorectum cancer surgery.

Observation group 2

Patients who suffered metachronous adenoma after distal colorectum cancer surgery.

Control group 2

Patients who do not suffered metachronous adenoma after distal colorectum cancer surgery.

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients underwent an exhaustive colorectal cancer surgical resection in the First Affiliated Hospital of Harbin Medical University from December 1, 2012 to April 28, 2017. Each participant provided a fresh stool sample in hospital before bowel preparation or 1 month after colonoscopy. All patients 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)

First affiliated hospital of Harbin medical university

Harbin, Heilongjiang, 150001, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Human fecal samples for DNA extraction

MeSH Terms

Conditions

Colorectal Neoplasms

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

Study Officials

• Yunwei Wei

  First Affiliated Hospital of Harbin Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunwei Wei

CONTACT

+86045185553099; hydwyw11@hotmail.com

Ye Jin

CONTACT

+8613936398339; hydjinye@hotmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: December 26, 2017
• Study Start: May 1, 2016
• Primary Completion: May 30, 2020
• Study Completion: September 30, 2020
• Last Updated: June 27, 2018

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)