Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00341458
First received: June 19, 2006
Last updated: March 14, 2014
Last verified: May 2013

June 19, 2006
March 14, 2014
August 1999
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Complete list of historical versions of study NCT00341458 on ClinicalTrials.gov Archive Site
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Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
Breast, Ovarian and Endometrial Cancer Case-Control Study in Poland

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).

The Polish breast, ovarian and endometrial cancer study is a molecular epidemiologic study conducted in two cities in Poland (Warsaw and L6dz) that enrolled 2,386 breast, 347 ovarian and 555 endometrial cancer cases, and 2,798 controls. 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. For a subset of cases we also obtained the pre-treatment mammograms to obtain mammographic density measures. Subject enrollment started in February 1, 2000. The last day of diagnosis for eligible breast cancer cases was January 31, 2003 and for ovarian and endometrial 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. We are continuing to obtain follow-up information and mortality information from breast, ovarian and endometrial cancer cases in the study using the Death Certificate Office database in Poland. The main research projects being conducted or planned for the near future include:

  1. Analyses of questionnaire-based factors and anthropometric measurements in relation to cancer risk and prognosis. This work has been addressed within the consent form documents as follows: "If you agree to participate, a trained interviewer from the Polish Sociological Association will administer a questionnaire about your reproductive history, diet, occupation, physical activity, and other factors related to health."
  2. Association between genetic susceptibility markers and cancer risk, mammographic density, risk factors, survival, and treatment using candidate gene and genome-wide association (GWAS) approaches. Genomic-wide association data has been acquired for the ER negative breast cancer cases, ovarian cancer cases, endometrial cancer cases and a subset of matched controls to evaluate genetic risk factors for these diseases. This work has been addressed within the consent form documents as follows: "The saliva, blood, urine, and tissue samples obtained will be used to look at factors that might be related to breast [ovarian/endometrial] disease. These factors include genes that are uncommon in the population but may dramatically increase the risk of breast [ovarian/endometrial] disease, and more common genes that are likely to cause a modest increase in breast [ovarian/endometrial] disease risk."
  3. Analyses of breast tissue/tumor markers to evaluate relationships with cancer risk factors (known or suspected), and their impact on predicting recurrence and survival after diagnosis. Biomarkers currently being evaluated include autoantibody profiles in plasma, metabolomic profiles in serum, levels of endogenous hormones and their metabolites in serum and adipose tissue, hormone levels in urine and breast tissue samples. Tumor markers are being analyzed using formalin fixed tissue samples (individual blocks or tissue cores in tissue microarrays) collected from about 2,000 breast, 200 ovarian and 400 endometrial cancer cases, and frozen tissue samples collected from a subset of about 300 breast cancer cases. Current tumor markers being analyzed include immunohistochemestry markers, DNA methylation, micro RNA profiling, mRNA profiling, cytogenetic changes using SNP arrays, and somatic mutations. This work has been addressed within the consent form documents as follows: "The saliva, blood, urine, and tissue samples obtained will be used to look at factors that might be related to breast [ovarian/endometrial] disease". In addition to tumor samples, we are collaborating with investigators to look at non-invasive tissues collected from the study.
  4. Confirmation of genetic associations and evaluation of risk factors for uncommon tumor subtypes requires large numbers of cases and controls that can only be attained in analyses of pooled data across individual studies. Therefore, we are collaborating with consortia of studies, particularly the Breast Cancer Association Consortium, the breast cancer CGEMS project, the Ovarian Cancer Association Consortium and the E2C2 Consortium of endometrial cancer studies.
Observational
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  • Endometrial Cancer
  • Ovarian Cancer
  • Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
6600
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  • 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).

Female
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT00341458
999999040, OH99-C-N040
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National Cancer Institute (NCI)
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Principal Investigator: Jonine Figueroa, Ph.D. National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP