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Colon Cancer Study of Fecal Samples in Shanghai, China

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ClinicalTrials.gov Identifier: NCT01778595
Recruitment Status : Completed
First Posted : January 29, 2013
Last Update Posted : July 2, 2017
Shanghai Center for Disease Control and Prevention
BGI, China
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Brief Summary:


- Early detection of colon cancer can improve the chances of successful treatment for most people. This approach is especially important if blood is detected in the stool. However, much better stool sample tests are needed to find this cancer early. To improve the tests, researchers want to collect samples from people who are already being screened for colon cancer. This study will collect information and samples from older adults in Shanghai, China. These adults will be participating in screening tests for colon cancer.


- To collect samples and medical information for colon cancer screening from older adults in Shanghai, China.


  • Adults between 50 and 74 years of age who are being screened for colon cancer.
  • Participants will be recruited from two community health centers in Shanghai, China.


  • Participants will provide information on their medical history and factors related to colon cancer. They will respond to questions on use of medications, diet choices (such as eating red meat), bowel habits, and other factors.
  • Participants will collect samples for study. These samples will be collected within 3 days of the screening visit. Particpants will provide a urine sample and four stool samples. They will also use cotton swabs to collect samples from just inside the anus. The samples will be returned to the study doctors for research tests that may indicate who has colon cancer.
  • Treatment will not be provided as part of this study.

Condition or disease
Colorectal Neoplasms

Detailed Description:
To examine how risk for colorectal cancer (CRC) is related to the microbes that inhabit the distal human intestine (the microbiota), we have proposed a large study that compares characteristics of the fecal microbiota in CRC patients and controls in the Shanghai population. In advance of that, we are proposing a small pilot study with the following two objectives: 1) determine participation rates among Shanghai adults, age 50-74 who are positive by fecal immunochemical test (FIT+); and 2) determine the suitability of fecal specimens provided by the participants for microbiome analyses. Each of two Shanghai community health centers, where CRC screening is ongoing, will recruit 25 FIT+ participants (half male; half age 50-64, half age 65-74). Each of the 50 participants will provide informed consent, brief questionnaire data, blood plasma and buffy coat, a urine specimen, and four samples of one stool, which will be frozen. Complete blood count and plasma glucose, cholesterol, and creatinine levels will be determined in real time and returned to the participant. Each participant s plasma, buffy coat, urine, and one pair of fecal samples will be stored frozen for future genetic or other assays. DNA will be extracted from the second pair of fecal samples from each participant (n=100 vials), amplified for 16S rRNA genes, and sequenced to determine fecal microbiome profiles. Participation will be deemed unsatisfactory if participation is <30% overall (95% confidence interval 17% - 43% for N=50 participants), or if there are <20 male, female, younger, or older participants. Specimen quality will be deemed unsatisfactory if the intraclass correlation coefficient (ICC) is <0.70 (95% confidence interval 0.53 0.82 for N=50 paired vials) for the Shannon index estimate of microbiome alpha diversity. As amended, the two community health centers will recruit up to 600 additional adults presenting for CRC screening, irrespective of FITstatus, who will be asked to provide saliva as well as the other specimens.

Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: Pilot Study of the Fecal Microbiome in the Shanghai Population
Study Start Date : January 8, 2013
Primary Completion Date : December 9, 2015
Study Completion Date : September 21, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement
U.S. FDA Resources

Primary Outcome Measures :
  1. Participation rate, data quality [ Time Frame: 1 year ]

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.

Ages Eligible for Study:   50 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Participation is restricted to adults age 50-74 who are: 1) residents of the catchment areas of the community health centers in Shanghai s Minhang and Xuhui Districts, and 2) are participating in the CRC screening program at those centers. Patients who do not provide signed informed consent will be excluded.

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): NCT01778595

Shanghai Center for Disease Control and Prevention
Shanghai, China
Sponsors and Collaborators
National Cancer Institute (NCI)
Shanghai Center for Disease Control and Prevention
BGI, China
Principal Investigator: James J Goedert, M.D. National Cancer Institute (NCI)

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01778595     History of Changes
Other Study ID Numbers: 999913068
First Posted: January 29, 2013    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: September 21, 2016

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Cancer Screening

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