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

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.

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Key information

Conditions

Lung Cancer Brain Cancer Brain Diseases Brain Neoplasms Breast Cancer Breast Diseases Breast Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lung Diseases Lung Neoplasms Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Non-Hodgkin Lymphoma Respiratory Tract Diseases Respiratory Tract Neoplasms Skin Diseases Skin and Connective Tissue Diseases Stomach Cancer Stomach Diseases Stomach Neoplasms Thoracic Neoplasms

Age range

40 year–70 year

Sex eligibility

Female

Study type

Observational

Primary location

Shanghai Cancer Institute

Shanghai, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

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

Treatment and study plan

Primary outcomes

All cancer incidence

Time frame: up to 30 years

Any cancer incidence, selected chronic diseases and all causemortality

Secondary outcomes

All deaths

Time frame: up to 30 years

All cause deaths

Sponsors and collaborators

Lead sponsor

National Cancer Institute (NCI)

Nih

Registry information

Important dates

Study start: 1997
Primary completion: 2020
Study completion: 2020
First posted: Jun 21, 2006
Registry last updated: Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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