Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

NCT03385213 | Unknown

• 1 other identifier: Yunwei Wei 2017 -2
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gut Microbiota; Colorectal Cancer

Keywords

Microbiota; colorectal cancer; relapse; surveillance

Outcome Measures

Primary Outcomes (1)

• Transcriptional changes in gut microbiota

  16S rRNA gene sequencing will be performed with stander procedure

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

Secondary Outcomes (1)

• Epigenetic changes

  Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery

Study Arms (2)

Relapse

Patients who suffered colorectal cancer relapse after curative surgery

Remission

Patients who get remission after curative surgery

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide. After curative treatment, however, 30% of patients with stage I-III and up to 65% of patients with stage IV CRC develop recurrent disease.

You may qualify if:

• 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

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 and gut 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

Yang Liu

CONTACT

+8618345180169

Study Design

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

Study Record Dates

• First Submitted: December 17, 2017
• First Posted: December 28, 2017
• Study Start: May 1, 2016
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2022
• Last Updated: May 9, 2018

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)