Colon Cancer Study of Fecal Samples in Shanghai, China
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Background:

      - 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.

      Objectives:

      - To collect samples and medical information for colon cancer screening from older adults in
      Shanghai, China.

      Eligibility:

        -  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.

      Design:

        -  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.
    

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.
    

Observational model: Ecologic or Community
Time perspective: Cross-Sectional
Keywords: Microbiome; Feces; Cancer Screening