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Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02845973
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : November 26, 2019
Sponsor:
Collaborators:
Shanghai 10th People's Hospital
Fudan University
Information provided by (Responsible Party):
Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine

Brief Summary:
The aim of the study is to identify and verify one or more gut bacteria of which the abundance in feces may help to early diagnosis colorectal cancer.

Condition or disease Intervention/treatment
Colorectal Neoplasms Biological: gut microbiota

Detailed Description:
Gut microbiota is closely related to human gut neoplasm. According to recent statistics, the abundance of FN (Fusobacterium Nucleatum) is connected with the development and progression of CRCs (colorectal cancers). Subsequent research shows identifying multiple microbial-specific genes in human feces using qPCR (quantitative Polymerase Chain Reaction) may help diagnosis of early stage colorectal cancer. Currently little is known about the relationship between single abundance of specific gut microbiota and colorectal cancer in different stage. Moreover, finding early-stage CRCs is still of great challenge partially due to precancerous diseases like colorectal adenoma which remain difficult to differentiate from early-stage CRC under endoscope. Conventional clinic methods predicting CRCs largely depend on serum CEA (serum Carcino Embryonic Antigen) and OB(fecal occult blood test), which lack of adequate sensitivity and specificity especially in early stage CRCs. The investigators' work focuses on the abundance of gut microbiota in feces from people with colon neoplasm and its comparison with classical indicators such as CEA and OB, aiming to reveal and testify its potential role on assisting diagnosis of CRCs in different stage as a none-invasive cost-effective method.

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Study Type : Observational
Actual Enrollment : 1325 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Actual Study Start Date : January 2012
Actual Primary Completion Date : June 2017
Actual Study Completion Date : July 2017

Group/Cohort Intervention/treatment
test cohort
The test cohort was from Fudan University Shanghai Cancer Center (August 2016 to December 2016) and ECRJ-East Campus of Renji hospital (January 2012 to March 2017);
Biological: gut microbiota
validation cohort
The validation cohort was from Shanghai Tenth People's Hospital (October 2015 to November 2016) and WCRJ-West Campus of Renji hospital (July 2016 to March 2017)
Biological: gut microbiota



Primary Outcome Measures :
  1. differences in abundance of gut microbiota [ Time Frame: 1 year ]
    differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction)


Secondary Outcome Measures :
  1. evidence of colorectal neoplasia [ Time Frame: 1 year ]
    Different outcomes for colorectal neoplasia confirmed by coloscopy


Other Outcome Measures:
  1. diet difference in patients with different clinical outcomes [ Time Frame: 1 year ]
    Diet difference in patients with different clinical outcomes by a food-frequency questionnaire


Biospecimen Retention:   Samples With DNA
feces of participants


Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Chinese people
Criteria

Inclusion Criteria:

  • Patients age from 40 to 85 years old
  • Patients with endoscopic or pathological confirmed healthy, adenoma, inflammation, early or late stage of colorectal cancer
  • Patients with valid CEA(carcino embryonic antigen) and OB(occult blood) test result in 1 year before or after the coloscopy or surgery

Exclusion Criteria:

  • Patients with history of colorectal cancer
  • Patients with long term use of antibiotics or probiotics
  • Patients with uncontrolled diabetes, hypertension or hepatitis
  • Patients with a history of subtotal gastrectomy or partial bowel resection
  • Patients who are not able to cooperate
  • Patients with medical conditions who are not appropriate to participate the study
  • Patients who are taking aspirin, NSAIDs (nonsteroidal antiinflammatory drugs), COX2(cyclo-oxygen-ase 2) inhibitors.

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): NCT02845973


Locations
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China
Shanghai Institute of Digestive Disease
Shanghai, China, 200001
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai 10th People's Hospital
Fudan University

Publications of Results:
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Responsible Party: Jing-yuan Fang, MD, Ph. D, Chief, Division of Gastroenterology and Hepatology, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT02845973    
Other Study ID Numbers: RJ20160701
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: November 26, 2019
Last Verified: November 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
Keywords provided by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine:
gut microbiota
Additional relevant MeSH terms:
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Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases