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Gut Microbiota Prediction of Metachronous Colorectal Neoplasms

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ClinicalTrials.gov Identifier: NCT03383159
Recruitment Status : Recruiting
First Posted : December 26, 2017
Last Update Posted : June 27, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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.

Condition or disease
Gut Microbiota Metachronous Adenoma

Detailed Description:

Colorectal cancer(CRC) is one of the most common malignancies in China and in Western countries. Furthermore, those with a history of CRC are at a higher risk for developing metachronous adenomas or CRC recurrence during the followup period. It has been reported that 0.7% of patients develop metachronous CRC during the 3 years after surgical resection for the initial CRC.

Surveillance colonoscopy is highly recommended by major international scientific societies with the intent of either detecting anastomotic recurrence at an early, curable stage or identifying metachronous premalignant(ie, adenomas) and malignant lesions. As life expectancy of patients with history of colon cancer is increasing, the costly and invasive postoperative examination increased the overall cost and suffering for patients.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While colonic microbiome development along the colorectal adenoma-carcinoma sequence. Investigators speculate that gut microbiota related to metachronous adenoma or CRC, after curative treatment.

This study aim to discover if any difference of gut microbiota exist in patients who suffer from metachronous adenomas compared with patients who do not. Further try to seek the divergence microbiota of metachronous adenomas between Proximal and Distal Colorectum. construct a predictive model of postoperative colorectal neoplasm development using microbiota analysis. Finally, using microbita construct a predictive model of postoperative colorectal neoplasm development.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Gut Microbiota Prediction of Metachronous Colorectal Neoplasms in Patients With Colorectal Cancer
Actual Study Start Date : May 1, 2016
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : September 30, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
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.



Primary Outcome Measures :
  1. Differences In Microbiota [ Time Frame: 1, 3 and 5 years after surgery ]
    The diversity, structure of microbiota and relative abundance of special bacterial taxa 16S rRNA gene sequencing will be performed.


Secondary Outcome Measures :
  1. Predictive model establish [ Time Frame: June to August of 2018 ]
    Using microbita construct a predictive model of postoperative colorectal neoplasm development.

  2. Predictive model validation [ Time Frame: August of 2018 to April of 2019 ]
    Validation the accuracy of the predictive model.


Biospecimen Retention:   Samples With DNA
Human fecal samples for DNA extraction


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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

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): NCT03383159


Contacts
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Contact: Yunwei Wei +86045185553099 hydwyw11@hotmail.com
Contact: Ye Jin +8613936398339 hydjinye@hotmail.com

Locations
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China, Heilongjiang
First affiliated hospital of Harbin medical university Recruiting
Harbin, Heilongjiang, China, 150001
Contact: Yunwei Wei    +86-0451-85553099    hydwyw11@hotmail.com   
Sponsors and Collaborators
First Affiliated Hospital of Harbin Medical University
Investigators
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Principal Investigator: 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: NCT03383159     History of Changes
Other Study ID Numbers: Yunwei Wei 2017-3
First Posted: December 26, 2017    Key Record Dates
Last Update Posted: June 27, 2018
Last Verified: October 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
Metachronous Adenoma
Colorectal Cancer
Colonoscopy

Additional relevant MeSH terms:
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Neoplasms
Colorectal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Colonic Diseases
Intestinal Diseases
Adenoma
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases