Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
Condition: Ovarian Neoplasms; Endometrial Neoplasms; Breast Neoplasms; Gonadal Disorders; Uterine Diseases
MeSH terms: Neoplasms; Breast Neoplasms; Ovarian Neoplasms; Endometrial Neoplasms; Uterine Diseases; Gonadal Disorders
Study type: Observational

Summary: 
      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)....
    

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 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 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
      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.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Eligible cases were women 20-74 years old, residents of Warsaw and Lodz that were newly
        diagnosed with confirmed in situ or invasive breast cancer between Jan 2000-Jan 2003, or
        ovarian or endometrial cancer diagnosed between June 2001-Dec 2003. A Rapid Identification
        System (RIS) was used at participating hospitals to identify eligible cases, and a Cancer
        Registry in Warsaw was used to identify cases missed by the RIS. Population control
        subjects were selected using the Polish @@@Electronic System, a database with demographic
        information from all residents of Poland. A random sample of women was chosen to represent
        the age distribution of women who develop breast, ovarian or endometrial cancer during the
        study period. Control selection was done on a quarterly basis from Jan 2000-June
        2004.@@@Controls identified through Sept 2003 were matched to breast cancer cases by city
        and age in 5-year categories. Endometrial and ovarian controls were identified from June
        2001-June 2004.
      
Keywords: Breast Cancer; Environment; Genetics; Epidemiology