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Colorectal Cancer Associated Host and Microbiome Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03998644
Recruitment Status : Recruiting
First Posted : June 26, 2019
Last Update Posted : July 2, 2019
Sponsor:
Information provided by (Responsible Party):
Huanlong Qin, Shanghai 10th People's Hospital

Brief Summary:
Recruit of healthy, precancer and colorectal cancer patients and record necessary information of demographic and also other messages. All the volunteers were asked to provide samples including stool, blood, urine and tissues. This protocol is performed with the permission of the ethics committee and all the participants were provided with informed consent.

Condition or disease
Colorectal Neoplasms

Detailed Description:
Healthy subjects, precancer patients identified by colonoscopy or colonoscopy history and colorectal cancer patients identified by two independent pathologists will be enrolled. The demographic message including age, weight, height, drug history, family history of all participants will be recorded. Blood, stool and urine samples will be collected of all subjects. Tumor and adjacent tissue samples of colorectal cancer and precancer patients were collected, as well as normal tissue of healthy subjects.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: A Study Focused on the Host and Microbiome of Colorectal Cancer Patients
Actual Study Start Date : December 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine


Group/Cohort
healthy
Subjects without colorectal disorders.
precancerous
Subjects with risk factors that may contribute to the carcinogenesis.
colorectal cancer
Patients who were identified by standard procedures to suffer with colorectal cancer.



Primary Outcome Measures :
  1. Gut microbiota structure and function difference between colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ]
    The results were based on the 16S rRNA metagenomic sequencing.


Secondary Outcome Measures :
  1. Metabolic difference of blood samples between colorectal cancer, precancer and healthy controls [ Time Frame: average of 5 years ]
    The metabolites of the blood samples by LC-MS will be detected.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Three different groups were created by healthy volunteers, precancerous and colorectal cancer patients. The information of these individuals will be analyzed and some conclusions will be drawn.
Criteria

Inclusion Criteria

  1. individuals who were clear and signed the informed consent.
  2. Male and female.
  3. Age >18

Exclusion Criteria:

  1. Any one who can not provide accurate information.
  2. Any one who denies the study.
  3. Younger than 18.

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): NCT03998644


Contacts
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Contact: Huanlong Qin, Ph.D 86-021-66301161 huanlqin@126.com

Locations
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China, Shanghai
Shanghai 10th People's Hospital Recruiting
Shanghai, Shanghai, China, 200072
Contact: Renyuan Gao, MD       renyuangao@126.com   
Principal Investigator: Huanlong Qin, PhD         
Sponsors and Collaborators
Shanghai 10th People's Hospital

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Responsible Party: Huanlong Qin, Professor, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT03998644     History of Changes
Other Study ID Numbers: CCAHMS
First Posted: June 26, 2019    Key Record Dates
Last Update Posted: July 2, 2019
Last Verified: June 2019
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

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