Study of Fecal Bacteria in Early Diagnosis of Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Colorectal Neoplasms

Intervention / Treatment
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* Biological: gut microbiota


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| test cohort<br>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<br> <br> |
| validation cohort<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| differences in abundance of gut microbiota | differences in abundance of gut microbiota for participants with different clinical outcomes confirmed by qPCR(quantitive polymerase chain reaction) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evidence of colorectal neoplasia | Different outcomes for colorectal neoplasia confirmed by coloscopy | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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gut microbiota