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Trial record 29 of 4147 for:    colon cancer AND Intestinal Neoplasms

Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapse

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ClinicalTrials.gov Identifier: NCT03385213
Recruitment Status : Recruiting
First Posted : December 28, 2017
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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.

Condition or disease
Gut Microbiota Colorectal Cancer

Detailed Description:

Treatments for colorectal cancer of all stages have evolved considerably over the past two decades, resulting in improved long-term outcomes. After curative treatment, however, 30% of patients with stage I-III and up to 65% of patients with stage IV colorectal cancer develop recurrent disease.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While the colonic microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that gut 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 gut 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 and should incorporate current knowledge on risk of recurrence in relation to the biology of the tumour as well as gut microbiota feature. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.


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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Retrospective
Official Title: Structural of the Gut Mucosal Microbiota is Associated With Colorectal Cancer Relapses After Curative Surgery
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Group/Cohort
Relapse
Patients who suffered colorectal cancer relapse after curative surgery
Remission
Patients who get remission after curative surgery



Primary Outcome Measures :
  1. Transcriptional changes in gut microbiota [ Time Frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery ]
    16S rRNA gene sequencing will be performed with stander procedure


Secondary Outcome Measures :
  1. Epigenetic changes [ Time Frame: Baseline, 6 months after surgery, 12 months after surgery, 24 months after surgery ]
    DNA methylation levels are analysed at baseline and after probiotics use in tissue samples


Biospecimen Retention:   Samples With DNA
Human fecal and gut mucosal samples for DNA extraction


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

  • 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

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03385213


Contacts
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Contact: Yunwei Wei +86045185553099 hydwyw11@hotmail.com
Contact: Yang Liu +8618345180169

Locations
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China, Heilongjiang
Yunwei Wei Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Yunwei Wei       hydwyw11@hotmail.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Study Director: Yunwei Wei First Affiliated Hospital of Harbin Medical University

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Responsible Party: First Affiliated Hospital of Harbin Medical University
ClinicalTrials.gov Identifier: NCT03385213     History of Changes
Other Study ID Numbers: Yunwei Wei 2017 -2
First Posted: December 28, 2017    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by First Affiliated Hospital of Harbin Medical University:
Microbiota
colorectal cancer
relapse
surveillance

Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Recurrence
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases
Disease Attributes
Pathologic Processes