NCT01778595

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2013

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 8, 2013

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2013

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 9, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 21, 2016

Completed
Last Updated

April 5, 2018

Status Verified

September 21, 2016

Enrollment Period

2.9 years

First QC Date

January 26, 2013

Last Update Submit

April 4, 2018

Conditions

Colorectal Neoplasms

Keywords

MicrobiomeFecesCancer Screening

Outcome Measures

Primary Outcomes (1)

  • Participation rate, data quality

    1 year

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shanghai Center for Disease Control and Prevention

Shanghai, China

Location

Related Publications (3)

  • Arthur JC, Perez-Chanona E, Muhlbauer M, Tomkovich S, Uronis JM, Fan TJ, Campbell BJ, Abujamel T, Dogan B, Rogers AB, Rhodes JM, Stintzi A, Simpson KW, Hansen JJ, Keku TO, Fodor AA, Jobin C. Intestinal inflammation targets cancer-inducing activity of the microbiota. Science. 2012 Oct 5;338(6103):120-3. doi: 10.1126/science.1224820. Epub 2012 Aug 16.

    PMID: 22903521BACKGROUND

  • Caporaso JG, Lauber CL, Walters WA, Berg-Lyons D, Huntley J, Fierer N, Owens SM, Betley J, Fraser L, Bauer M, Gormley N, Gilbert JA, Smith G, Knight R. Ultra-high-throughput microbial community analysis on the Illumina HiSeq and MiSeq platforms. ISME J. 2012 Aug;6(8):1621-4. doi: 10.1038/ismej.2012.8. Epub 2012 Mar 8.

    PMID: 22402401BACKGROUND

  • Goedert JJ, Gong Y, Hua X, Zhong H, He Y, Peng P, Yu G, Wang W, Ravel J, Shi J, Zheng Y. Fecal Microbiota Characteristics of Patients with Colorectal Adenoma Detected by Screening: A Population-based Study. EBioMedicine. 2015 Apr 18;2(6):597-603. doi: 10.1016/j.ebiom.2015.04.010. eCollection 2015 Jun.

    PMID: 26288821BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • James J Goedert, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 26, 2013

First Posted

January 29, 2013

Study Start

January 8, 2013

Primary Completion

December 9, 2015

Study Completion

September 21, 2016

Last Updated

April 5, 2018

Record last verified: 2016-09-21

Locations

CN(1)