Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00342004
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2006-06-19
Brief Title:
A Prospective Cohort Study of Occupational Exposures and Cancer Risk Among Women
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
A Prospective Cohort Study of Occupational Exposures and Cancer Risk Among Women
Status:
COMPLETED
Status Verified Date:
2020-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
A prospective cohort study is proposed to evaluate occupational and environmental risk factors for cancer among women in Shanghai China Approximately 75000 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 35 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 75000 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 35 years We anticipate however that follow-up will continue for 10 years or more
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| OH98-C-N006 | None | None | None |