Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
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Purpose
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 |
|---|
|
Endometrial Cancer Ovarian Cancer Breast Cancer |
| Study Type: | Observational |
| Official Title: | Breast, Ovarian and Endometrial Cancer Case-Control Study in Poland |
Eligibility| Ages Eligible for Study: | 20 Years to 74 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
- INCLUSION CRITERIA:
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).
Contacts and Locations| Poland | |
| Nofer Institute of Occupational Medicine | |
| Lodz, Poland | |
| Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology | |
| Warsaw, Poland | |
| Principal Investigator: | Jonine Figueroa, Ph.D. | National Cancer Institute (NCI) |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00341458 History of Changes |
| Other Study ID Numbers: | 999999040, OH99-C-N040 |
| Study First Received: | June 19, 2006 |
| Last Updated: | May 7, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Breast Cancer Environment Genetics Epidemiology |
Additional relevant MeSH terms:
|
Breast Neoplasms Endometrial Neoplasms Sarcoma, Endometrial Stromal Ovarian Neoplasms Adenoma Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Uterine Neoplasms Genital Neoplasms, Female Urogenital Neoplasms Uterine Diseases |
Genital Diseases, Female Neoplasms, Complex and Mixed Neoplasms by Histologic Type Sarcoma Neoplasms, Connective and Soft Tissue Endometrial Stromal Tumors Endocrine Gland Neoplasms Ovarian Diseases Adnexal Diseases Endocrine System Diseases Gonadal Disorders Neoplasms, Glandular and Epithelial |
ClinicalTrials.gov processed this record on May 16, 2013