Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Unknown
Verified July 2016 by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine.
Recruitment status was:  Recruiting
First Posted : July 27, 2016
Last Update Posted : July 27, 2016
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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Study Start Date : June 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Retrospective cohort
cohort includes patients with and without colorectal neoplasia from 2011.6 through 2016.1 who are over 40 years old and have a valid CEA(carcino embryonic antigen) and OB(occult blood) test results, as well as a valid coloscopy. The constitution of gut microbiota for each group will be studied and compared to establish a new diagnosis model for colorectal cancer.
Biological: gut microbiota
Prospective cohort
cohort includes patients with and without colorectal neoplasia from 2016.2 through 2016.9 who are over 40 years old and have a valid CEA(carcino embryonic antigen) and OB(occult blood) test results. The constitution of gut microbiota for each group will be studied and compared following by a coloscopy to verify the diagnosis model.
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 85 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


Contacts
Layout table for location contacts
Contact: Jingyuan Fang, MD. Ph.D 86-21-53882450 jingyuanfang@sjtu.edu.cn

Locations
Layout table for location information
China
Shanghai Institute of Digestive Disease Recruiting
Shanghai, China, 200001
Principal Investigator: jing-yuan Fang, MD. Ph D.         
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Shanghai 10th People's Hospital
Fudan University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
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     History of Changes
Other Study ID Numbers: RJ20160701
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: July 27, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Jing-yuan Fang, MD, Ph. D, Shanghai Jiao Tong University School of Medicine:
gut microbiota

Additional relevant MeSH terms:
Layout table for MeSH terms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases