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: May 14, 2014
Last verified: April 2014
  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
Ovarian Neoplasms
Endometrial Neoplasms
Breast Neoplasms
Gonadal Disorders
Uterine Diseases

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Breast, Ovarian and Endometrial Cancer Case-Control Study in Poland

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Breast cancer [ Time Frame: incident ] [ Designated as safety issue: No ]

Estimated Enrollment: 6600
Study Start Date: August 1999
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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria
  • 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00341458

Locations
Poland
Nofer Institute of Occupational Medicine
Lodz, Poland
Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology
Warsaw, Poland
Sponsors and Collaborators
Investigators
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 14, 2014
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
Neoplasms
Endometrial Neoplasms
Gonadal Disorders
Ovarian Neoplasms
Uterine Diseases
Neoplasms by Site
Breast Diseases
Skin Diseases
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Genital Diseases, Female
Endocrine System Diseases
Endocrine Gland Neoplasms
Ovarian Diseases
Adnexal Diseases

ClinicalTrials.gov processed this record on July 24, 2014