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

NCT ID: NCT00342004

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 75366 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1997-05-01
• Study Completion Date: 2020-07-28

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.

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.

Conditions

Lung Cancer; Non-Hodgkin Lymphoma; Breast Cancer; Stomach Cancer; Brain Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy Volunteers

Healthy female urban residents in Shanghai between ages of 40-70.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Qing Lan, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

Shanghai Cancer Institute

Shanghai, , China

Countries

China

References

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.

Reference Type: BACKGROUND

PMID: 7796202 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8449643 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8837680 (View on PubMed)

Other Identifiers

OH98-C-N006

Identifier Type: -

Identifier Source: secondary_id

999998006

Identifier Type: -

Identifier Source: org_study_id