Colon Cancer Study of Fecal Samples in Shanghai, China
| Status: | Completed |
|---|---|
| Conditions: | Colorectal Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 50 - 75 |
| Updated: | 11/30/2013 |
| Start Date: | January 2013 |
| End Date: | October 2015 |
| Contact: | James J Goedert, M.D. |
| Email: | goedertj@mail.nih.gov |
| Phone: | (301) 435-4724 |
Pilot Study of the Fecal Microbiome in the Shanghai Population
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.
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/EXCLUSION 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.
We found this trial at
1
site
9609 Medical Center Drive
Bethesda, Maryland 20892
Bethesda, Maryland 20892
1-800-422-6237
National Cancer Institute , 9000 Rockville Pike The National Cancer Institute (NCI) is part of...
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