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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Institutes of Health Clinical Center (CC) |
ClinicalTrials.gov Identifier: | NCT00341458 |
The Polish breast, ovarian and endometrial cancer study is a complex molecular epidemiologic study that is expected to enroll about 2,500 breast cancer, 450 ovarian and 450 endometrial cancer cases and 2,500 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, plasma+buffy coat+red 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 2,207 breast, 138 ovarian and 235 endometrial cancer cases and 2,327 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).
Condition |
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Endometrial Cancer Ovarian Cancer Breast Cancer |
Study Type: | Observational |
Official Title: | Breast, Ovarian and Endometrial Cancer Case-Control Study in Poland |
Estimated Enrollment: | 6600 |
Study Start Date: | August 1999 |
Estimated Primary Completion Date: | September 2002 (Final data collection date for primary outcome measure) |
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 has enrolled 2,386 breast cancer cases and 2,503 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, plasma+buffy coat+red 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, 2000. The 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 agree 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 immunohistochemical/immunofluorescence stains to evaluate etiologic heterogeneity of breast cancer risk factors by tumor type.
For the ovarian/endometrial 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 ovarian/endometrial components and construction of tissue microarrays for endometrial cases is planned for 2005-06.
Ages Eligible for Study: | 20 Years to 74 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Cases for study will consist of all women ages 20-74 years who are newly diagnosed with either histologically or cytologically confirmed in situ or invasive breast cancers during the two and a half year study period.
In both Warsaw and Lodz, controls will be selected using the Polish Electronic System of Population Evidence localized in Warsaw (PESEL).
Study ID Numbers: | 999999040, OH99-C-N040 |
Study First Received: | June 19, 2006 |
Last Updated: | September 2, 2009 |
ClinicalTrials.gov Identifier: | NCT00341458 History of Changes |
Health Authority: | United States: Federal Government |
Breast Cancer Environment Genetics Epidemiology |
Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Uterine Diseases Breast Neoplasms Endocrine System Diseases Endometrial Cancer Urogenital Neoplasms |
Ovarian Diseases Genital Diseases, Female Endometrial Neoplasms Ovarian Cancer Uterine Neoplasms Endocrinopathy Breast Diseases Endocrine Gland Neoplasms |
Ovarian Neoplasms Skin Diseases Gonadal Disorders Genital Neoplasms, Female Uterine Diseases Endocrine System Diseases Breast Neoplasms Urogenital Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Diseases, Female Endometrial Neoplasms Neoplasms Neoplasms by Site Uterine Neoplasms Breast Diseases Endocrine Gland Neoplasms |