Know Cancer

forgot password

Pilot Study of the Fecal Microbiome in the Shanghai Population

50 Years
75 Years
Open (Enrolling)
Colorectal Neoplasms

Thank you

Trial Information

Pilot Study of the Fecal Microbiome in the Shanghai Population

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 FITplus
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 coar, 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 equals100 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.

Inclusion Criteria


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. Further, because a future
study would focus on CRC, which occurs predominantly in people who are FIT+, the current
pilot study is restricted to patients whose screening for CRC reveals that they are FIT+.
Patients who do not provide signed informed consent will be excluded.

Type of Study:


Study Design:


Outcome Measure:

Participation rate

Outcome Time Frame:

6 months

Safety Issue:


Principal Investigator

James J Goedert, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

National Cancer Institute (NCI)


United States: Federal Government

Study ID:




Start Date:

January 2013

Completion Date:

October 2015

Related Keywords:

  • Colorectal Neoplasms
  • Microbiome
  • Feces
  • Cancer Screening
  • Neoplasms
  • Colorectal Neoplasms



National Cancer Institute (NCI), 9000 Rockville Pike Bethesda, Maryland  20892