- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00342004
A Prospective Cohort Study of Occupational Exposures and Cancer Risk Among Women
July 31, 2020 updated by: National Cancer Institute (NCI)
A prospective cohort study is proposed to evaluate occupational and environmental risk factors for cancer among women in Shanghai, China.
Approximately 75,000 women aged 40-69 who reside in eight geographically defined communities in two urban districts of Shanghai will be recruited via a community-based cancer education program.
All eligible subjects will be invited by local health workers from the neighborhood health station to the clinic for an interview and selected anthropometric measurements.
The interview will elicit information on demographic background, diet, lifestyle factors, medical history, lifetime occupational history and residential history for the past 20 years.
In addition, the women will be asked for information on their husbands' current and usual occupations, and demographic and a few other exposure factors.
A spot urine sample and 10 ml of blood will be collected from all cohort members and stored at -70 degrees C for future assays of urine metabolites and DNA and hemoglobin adducts of selected occupational and environmental carcinogens, and polymorphic genes encoding enzymes that are involved in metabolism of relevant carcinogens.
Cohort members and their husbands will be followed for cancer outcomes through biennial recontact and linkage with files of the population-based Shanghai Cancer Registry, of the Shanghai Vital Statistics, and of the Shanghai Resident Registry.
Medical records and pathology slides will be reviewed for all cancer cases to verify their diagnosis.
Post-diagnostic blood samples will be obtained from all cohort members diagnosed with cancer during the follow-up period and stored for future methodologic and etiologic studies.
The proposed initial study period is 5 years, with an average follow-up of about 3.5 years.
We anticipate, however, that follow-up will continue for 10 years or more.
Study Overview
Status
Completed
Detailed Description
A prospective cohort study is proposed to evaluate occupational and environmental risk factors for cancer among women in Shanghai, China.
Approximately 75,000 women aged 40-69 who reside in eight geographically defined communities in two urban districts of Shanghai will be recruited via a community-based cancer education program.
All eligible subjects will be invited by local health workers from the neighborhood health station to the clinic for an interview and selected anthropometric measurements.
The interview will elicit information on demographic background, diet, lifestyle factors, medical history, lifetime occupational history and residential history for the past 20 years.
In addition, the women will be asked for information on their husbands' current and usual occupations, and demographic and a few other exposure factors.
A spot urine sample and 10 ml of blood will be collected from all cohort members.
Among participants who did not provide a blood sample, a buccal cell sample will be collected.
All biological samples will be stored at -70 degrees C for future assays of genetic polymorphisms, urine metabolites and DNA and hemoglobin adducts of selected occupational and environmental carcinogenACs.
Cohort members and their husbands will be followed for cancer outcomes through annual recontact and linkage with files of the population-based Shanghai Cancer Registry, of the Shanghai Vital Statistics, and of the Shanghai Resident Registry.
Medical records and pathology slides will be reviewed for all cancer cases to verify their diagnosis.
Post-diagnostic blood samples will be obtained from all cohort members diagnosed with cancer during the follow-up period and stored for future methodologic and etiologic studies.
The proposed initial study period is 5 years, with an average follow-up of about 3.5 years.
We anticipate, however, that follow-up will continue for 10 years or more.
Study Type
Observational
Enrollment (Actual)
75366
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Shanghai, China
- Shanghai Cancer Institute
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Healthy female urban residents in Shanghai between ages of 40-70.
Description
- INCLUSION CRITERIA:
Women aged 40-69 who are permanent residents in eight geographically defined communities of urban Shanghai.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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Healthy Volunteers
Healthy female urban residents in Shanghai between ages of 40-70.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All cancer incidence
Time Frame: up to 30 years
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Any cancer incidence, selected chronic diseases and all causemortality
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up to 30 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
All deaths
Time Frame: up to 30 years
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All cause deaths
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up to 30 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cantor KP, Stewart PA, Brinton LA, Dosemeci M. Occupational exposures and female breast cancer mortality in the United States. J Occup Environ Med. 1995 Mar;37(3):336-48. doi: 10.1097/00043764-199503000-00011.
- Chow WH, Dosemeci M, Zheng W, Vetter R, McLaughlin JK, Gao YT, Blot WJ. Physical activity and occupational risk of colon cancer in Shanghai, China. Int J Epidemiol. 1993 Feb;22(1):23-9. doi: 10.1093/ije/22.1.23.
- Chow WH, Ji BT, Dosemeci M, McLaughlin JK, Gao YT, Fraumeni JF Jr. Biliary tract cancers among textile and other workers in Shanghai, China. Am J Ind Med. 1996 Jul;30(1):36-40. doi: 10.1002/(SICI)1097-0274(199607)30:13.0.CO;2-Q.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 1997
Primary Completion (Actual)
July 28, 2020
Study Completion (Actual)
July 28, 2020
Study Registration Dates
First Submitted
June 19, 2006
First Submitted That Met QC Criteria
June 19, 2006
First Posted (Estimate)
June 21, 2006
Study Record Updates
Last Update Posted (Actual)
August 4, 2020
Last Update Submitted That Met QC Criteria
July 31, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms
- Neoplasms by Site
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Stomach Diseases
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Stomach Neoplasms
- Brain Neoplasms
Other Study ID Numbers
- 999998006
- OH98-C-N006
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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