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Epidemiological Study of Colorectal Cancer in WuHan

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Wuhan University
Hubei Cancer Hospital
Huazhong University of Science and Technology
Wuhan Iron and Steel Workers' Hospital
Information provided by (Responsible Party):
Wuhan Pu-Ai Hospital
ClinicalTrials.gov Identifier:
NCT01863303
First received: May 22, 2013
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

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
Diarrhea
Constipation
Melena
Neoplasm
Colonic Neoplasms
Pain

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Epidemiological Study of Colorectal Cancer in WuHan

Resource links provided by NLM:


Further study details as provided by Wuhan Pu-Ai Hospital:

Primary Outcome Measures:
  • incidence of CRC [ Time Frame: June 2022 (up to 10 years) ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples With DNA

Blood sample or neoplasm from high risk group


Estimated Enrollment: 1
Study Start Date: June 2012
Estimated Study Completion Date: June 2018
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 74 Years
Genders Eligible for Study:   Both
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

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Investigators
Study Director: Yan Li, doctor Zhongnan hospital of Wuhan university, China
  More Information

No publications provided

Responsible Party: Wuhan Pu-Ai Hospital
ClinicalTrials.gov Identifier: NCT01863303     History of Changes
Other Study ID Numbers: R201206DCAPC
Study First Received: May 22, 2013
Last Updated: May 24, 2013
Health Authority: China: Ministry of Health

Keywords provided by Wuhan Pu-Ai Hospital:
colorectal cancer
epidemiology
industry
genetic

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

ClinicalTrials.gov processed this record on November 20, 2014