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Trial record 32 of 4077 for:    colon cancer AND Intestinal Neoplasms

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

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ClinicalTrials.gov Identifier: NCT03667495
Recruitment Status : Recruiting
First Posted : September 12, 2018
Last Update Posted : September 21, 2018
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital of Harbin Medical University

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.

Condition or disease
Gut Microbiota Oral Microbiota Colorectal Cancer

Detailed Description:

Colorectal cancer is a major cause of cancerrelated deaths and the third most commonly diagnosed cancer worldwide.Current estimates indicate that 20-30% of those who undergo treatment will experience recurrence and 35% of all patients will die within 5 years.

The human colon plays host to a diverse and metabolically complex community of microorganisms. While the specific oral microbiome has been found to contribute to the development of colorectal cancer. Investigators speculate that specific oral 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 oral 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. Finally investigators will develop patient-centred programmes of surveillance protocols base on microbiota analysis.


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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Postoperative Oral and Intestinal Flora Changes in Patients With Colorectal Cancer and the Relationship Between These Changes and Prognosis
Actual Study Start Date : November 1, 2017
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : March 1, 2021

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Colorectal cancer or adenoma recurred [ Time Frame: 12 months after surgery ]
    Use colonoscopy to check for recurrence of colorectal cancer


Biospecimen Retention:   Samples With DNA
Human fecal, oral and mucosal samples for DNA extraction.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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): NCT03667495


Contacts
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Contact: Yunwei Wei +86045185553099 hydwyw11@hotmail.com
Contact: Rui Geng +8613263695371 gengruihyd@163.com

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: NCT03667495     History of Changes
Other Study ID Numbers: Yunwei Wei 2018-09-04
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 21, 2018
Last Verified: September 2018
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
recurrence

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
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases