Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00341458
Status:
COMPLETED
Last Update Posted:
2020-04-20
First Post:
2006-06-19
Brief Title:
Breast Cancer in Poland An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
Sponsor:
National Cancer Institute NCI
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Breast Ovarian and Endometrial Cancer Case-Control Study in Poland
Status:
COMPLETED
Status Verified Date:
2020-04
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:
The Polish breast ovarian and endometrial cancer study is a complex molecular epidemiologic study that is expected to enroll about 2500 breast cancer 450 ovarian and 450 endometrial cancer cases and 2500 controls from Warsaw and Lodz two major cities in Poland This large population-based study combines state-of-the-art techniques of exposure assessment and collection of biological specimens to allow for the study of a wide range of biomarkers Exposure information is obtained through detailed personal interviews anthropometric measurements physical activity monitors and collection of dust samples from the participants homes The collection of biological specimens includes blood samples processed as cryopreserved whole blood serum blood clot plasmabuffy coatred blood cells 12-hour overnight urine paraffin embedded tumor and normal tissue and fresh tissue from tumors non-neoplastic breast tissue and mammary fat tissue Subject enrollment started in June 2000 and is expected to continue until January 2003 for breast cancer cases and controls and June 2003 for ovarian and endometrial cancer cases As of May 2002 we have identified 2207 breast 138 ovarian and 235 endometrial cancer cases and 2327 controls The response rates to the interview are 81 for breast 90 for ovarian and 83 for endometrial cancer cases and 70 for controls Most women who agree to the interview agree to provide biological specimens about 90 of cancer cases and controls agree to provide a blood sample anthropometric measurements 95 of breast cancer cases and controls and wear a physical activity monitor 79 breast cancer cases and 90 of controls
Detailed Description:
The Polish breast ovarian and endometrial cancer study is a complex molecular epidemiologic study conducted in two major cities in Poland Warsaw and Lodz that enrolled 2386 breast cancer cases and 2503 controls and is expected to enroll about 400 ovarian 600 endometrial cancer cases and 600 additional controls by September 2004 This large population-based study combines state-of-the art techniques of exposure assessment and collection of biological specimens to allow for the study of a wide range of biomarkers Exposure information is obtained through detailed personal interviews anthropometric measurements physical activity monitors and collection of dust samples from the participants homes The collection of biological specimens includes blood samples processed as cryopreserved whole blood serum blood clot plasmabuffy coatred blood cells 12-hour overnight urine paraffin embedded tumor and normal tissue and fresh tissue from tumors non-neoplastic breast tissue and mammary fat tissue Subject enrollment started in June 1 2000The last day of diagnosis for eligible breast cancer cases was December 31 2003 The final response rates to the interview for the breast cancer component of the study are 79 for breast cancer cases and 69 for controls Among women who agree to the interview most of them agree to provide biological specimens 84 of breast cancer cases and 92 of controls agree to provide a blood sample 82 of cases and 89 of controls agree to provide a urine sample anthropometric measurements 95 of breast cancer cases and 93 controls and wear a physical activity monitor 76 of breast cancer cases and 84 of controls from the Warsaw study site The final participation rates to the interview for the ovarian and endometrial component of the study are 78 for ovarian 80 for endometrial cancer cases Of these women 85 of ovarian and 86 of endometrial cancer cases agreed to provide a blood sample Urine samples anthropmetric measurements physical activity monitor data are not collected from ovarian and endometrial cases We are currently working on the first manuscripts from the breast cancer component of the study We have completed DNA extractions and the first genotype assays In addition we constructed tissue microarrays using formalin fixed tumor samples from breast cancer cases with invasive cancer and performed a number of immunohistochemicalimmunofluorescence stains to evaluate etiologic heterogeneity of breast cancer risk factors by tumor type For the ovarianendometrial component of the study we have completed the DNA extractions for all subjects and incited the first analyses for endometrial study Determination of the first genotypes for the ovarianendometrial components and construction of tissue microarrays for endometrial cases is planned for 2005- 06
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 |
|---|---|---|---|
| OH99-C-N040 | None | None | None |