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Epidemiological Study of Colorectal Cancer in WuHan

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01863303
Recruitment Status : Active, not recruiting
First Posted : May 27, 2013
Last Update Posted : May 27, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:

The incidence risk of colorectal cancer (CRC) is increasing at 4.2% year by year in China. Most effective way to reduce the death rate of CRC patients is to diagnose in quite an early stage. QiaoKou District is a chemical industry Zone of Wuhan with a long history, which has few data of CRC epidemiology. The investigators design the primary CRC screening for this district by healthy questionnaire, Fecal Occult Blood Test(FOBT) and colonoscopy. HanYang Areo has been chosen as Control for its non-industry environment.The crowd would be screen biennially. The high risk group would be intervened, such as resection of polyps or other specific treatment. A follow-up registration database has been built for analysis the relationship between incidence or death rate to high risk factors, such as age, life environment, lifestyles, base diseases and family history of cancer.

This study will provide some epidemiology dates of CRC to the local Government, and assist the governor to built a more effective screening system of CRC.

Condition or disease
Diarrhea Constipation Melena Neoplasm Colonic Neoplasms Pain

Detailed Description:

For this study, you will be asked to complete a personal interview. During the interview, you will be asked questions about your demographics (age, sex, etc.), underlying diseases, lifestyle, family history of cancer, awareness of CRC. It should take around 30 minutes to complete the interview.

Residents in high risk group need to have some special tests, including FOBT and colonoscopy. Intestinal neoplasm will be suggested to biopsy or remove under colonoscopy for pathological examination. All tests are free. The interviews will be performed in Residential area and special tests will be done in the hospital during a regularly scheduled visit to Pu-Ai hospita.You may be contacted at home by phone so that researchers can collect information about any changes in your health status.

Study Design

Study Type : Observational
Estimated Enrollment : 1 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study of Colorectal Cancer in WuHan
Study Start Date : June 2012
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :
  1. incidence of CRC [ Time Frame: June 2022 (up to 10 years) ]

Biospecimen Retention:   Samples With DNA
Blood sample or neoplasm from high risk group

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Coulp of this study from a chemical industry Zone of Wuhan with a long history,seriously polluted environment, which has few data of CRC epidemiology.

HanYang Areo has been choosen as Control for its non-industry environment


Inclusion Criteria:

  1. Aged 40-74
  2. Resident of Qiaokou Areo,and at least ten years living history in this district
  3. Willing and able to provide written informed consent and authorization
  4. Willing to a personal interview and have some special tests

Exclusion Criteria:

  1. Under 43 or older than 74 years of age
  2. History of colorectal cancer
  3. Mental disorders
Contacts and Locations

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): NCT01863303

Sponsors and Collaborators
Wuhan Pu-Ai Hospital
Wuhan University
Hubei Cancer Hospital
Huazhong University of Science and Technology
Wuhan Iron and Steel Workers' Hospital
Study Director: Yan Li, doctor Zhongnan hospital of Wuhan university, China
More Information

Responsible Party: Wuhan Pu-Ai Hospital
ClinicalTrials.gov Identifier: NCT01863303     History of Changes
Other Study ID Numbers: R201206DCAPC
First Posted: May 27, 2013    Key Record Dates
Last Update Posted: May 27, 2013
Last Verified: May 2013

Keywords provided by Wuhan Pu-Ai Hospital:
colorectal cancer

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