COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Prospective Cohort Study of Occupational Exposures and Cancer Risk Among Women

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: NCT00342004
Recruitment Status : Completed
First Posted : June 21, 2006
Last Update Posted : August 4, 2020
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) )

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Lung Cancer Non-Hodgkin Lymphoma Breast Cancer Stomach Cancer Brain Cancer

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 75366 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Cohort Study of Occupational Exposures and Cancer Risk Among Women
Actual Study Start Date : May 1, 1997
Actual Primary Completion Date : July 28, 2020
Actual Study Completion Date : July 28, 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Healthy Volunteers
Healthy female urban residents in Shanghai between ages of 40-70.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. All cancer incidence [ Time Frame: up to 30 years ]
    Any cancer incidence, selected chronic diseases and all causemortality


Secondary Outcome Measures :
  1. All deaths [ Time Frame: up to 30 years ]
    All cause deaths


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Healthy female urban residents in Shanghai between ages of 40-70.
Criteria
  • INCLUSION CRITERIA:

Women aged 40-69 who are permanent residents in eight geographically defined communities of urban Shanghai.

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT00342004


Locations
Layout table for location information
China
Shanghai Cancer Institute
Shanghai, China
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Qing Lan, M.D. National Cancer Institute (NCI)
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00342004    
Other Study ID Numbers: 999998006
OH98-C-N006
First Posted: June 21, 2006    Key Record Dates
Last Update Posted: August 4, 2020
Last Verified: July 2020
Keywords provided by National Institutes of Health Clinical Center (CC) ( National Cancer Institute (NCI) ):
Shanghai
Residential History
Exposure Assessment
Cohort Study
Molecular Epidemiology
Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Neoplasms
Stomach Neoplasms
Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases