DiarrheaNCT01863303
Epidemiological Study of Colorectal Cancer in WuHan
An observational study of Diarrhea and Constipation, run by Wuhan Pu-Ai Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Diarrhea, Constipation, Melena
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Aged 40-74
- Resident of Qiaokou Areo，and at least ten years living history in this district
- Willing and able to provide written informed consent and authorization
- Willing to a personal interview and have some special tests
Who cannot join
- Under 43 or older than 74 years of age
- History of colorectal cancer
- Mental disorders
About this study
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.
Read the 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.
- Conditions
- Diarrhea, Constipation, Melena, Neoplasm, Colonic Neoplasms, Pain
- Keywords
- colorectal cancer, epidemiology, industry, genetic
- Medical subject headings
- Diarrhea, Constipation, Melena, Neoplasms, Colonic Neoplasms, Pain, Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of CRC
Measured: June 2022 (up to 10 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2013 (estimated)
- Study startJun 2012
- Primary completionJun 2017 (estimated)
- Study completionJun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wuhan Pu-Ai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Wuhan University, Hubei Cancer Hospital, Huazhong University of Science and Technology, Wuhan Iron and Steel Workers' Hospital
- Responsible party
- Sponsor
- Investigators
- Yan Li, doctor, Study director, Zhongnan hospital of Wuhan university, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01863303
- Sponsor's protocol ID
- R201206DCAPC
- Status last verified
- May 2013
- First submitted
- 22 May 2013
- Last updated
- 27 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiological Study of Colorectal Cancer in WuHan
- ClinicalTrials.gov ID
- NCT01863303
- Acronym / sponsor ID
- R201206DCAPC
- Conditions
- Diarrhea, Constipation, Melena, Neoplasm, Colonic Neoplasms, Pain
- Keywords
- colorectal cancer, epidemiology, industry, genetic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Wuhan Pu-Ai HospitalUniversity, hospital or other
- Collaborators
- Wuhan University, Hubei Cancer Hospital, Huazhong University of Science and Technology, Wuhan Iron and Steel Workers' Hospital
- Study start
- Jun 2012
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jun 2018 (estimated)
- First posted
- 27 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Aged 40-74
- Resident of Qiaokou Areo，and at least ten years living history in this district
- Willing and able to provide written informed consent and authorization
- Willing to a personal interview and have some special tests
Key exclusion criteria (3 listed)
- Under 43 or older than 74 years of age
- History of colorectal cancer
- Mental disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
incidence of CRC
Time frame: June 2022 (up to 10 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yan Li, doctor study director
Zhongnan hospital of Wuhan university, China
Questions about this trial
What is this clinical trial studying?
An observational study of Diarrhea and Constipation, run by Wuhan Pu-Ai Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of CRC (time frame: June 2022 (up to 10 years)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2013.