NCT00341458

Brief 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)....

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6,086

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 1999

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1999

Completed
6.8 years until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
13.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 16, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2020

Completed
Last Updated

April 20, 2020

Status Verified

April 1, 2020

Enrollment Period

20.6 years

First QC Date

June 19, 2006

Last Update Submit

April 16, 2020

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsBreast NeoplasmsGonadal DisordersUterine Diseases

Keywords

Breast CancerEnvironmentGeneticsEpidemiology

Outcome Measures

Primary Outcomes (3)

  • Breast cancer

    Pathologically confirmed diagnosis of breast cancer

    incident

  • Ovarian cancer

    Pathologically confirmed diagnosis of ovarian cancer

    incident

  • Endometrial cancer

    Pathologically confirmed diagnosis of endometrial cancer

    incident

Study Arms (1)

Cancer Cases

Women 20-74 years old, residents of Warsaw and Lodz that were newly diagnosed with confirmed in situ or invasive breast cancer or ovarian or endometrial cancer

Eligibility Criteria

Age20 Years - 74 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Nofer Institute of Occupational Medicine

Lodz, Poland

Location

Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology

Warsaw, Poland

Location

Related Publications (4)

  • Garcia-Closas M, Brinton LA, Lissowska J, Chatterjee N, Peplonska B, Anderson WF, Szeszenia-Dabrowska N, Bardin-Mikolajczak A, Zatonski W, Blair A, Kalaylioglu Z, Rymkiewicz G, Mazepa-Sikora D, Kordek R, Lukaszek S, Sherman ME. Established breast cancer risk factors by clinically important tumour characteristics. Br J Cancer. 2006 Jul 3;95(1):123-9. doi: 10.1038/sj.bjc.6603207. Epub 2006 Jun 6.

    PMID: 16755295BACKGROUND

  • Garcia-Closas M, Brinton LA, Lissowska J, Richesson D, Sherman ME, Szeszenia-Dabrowska N, Peplonska B, Welch R, Yeager M, Zatonski W, Chanock SJ. Ovarian cancer risk and common variation in the sex hormone-binding globulin gene: a population-based case-control study. BMC Cancer. 2007 Apr 5;7:60. doi: 10.1186/1471-2407-7-60.

    PMID: 17411440BACKGROUND

  • Garcia-Closas M, Egan KM, Newcomb PA, Brinton LA, Titus-Ernstoff L, Chanock S, Welch R, Lissowska J, Peplonska B, Szeszenia-Dabrowska N, Zatonski W, Bardin-Mikolajczak A, Struewing JP. Polymorphisms in DNA double-strand break repair genes and risk of breast cancer: two population-based studies in USA and Poland, and meta-analyses. Hum Genet. 2006 May;119(4):376-88. doi: 10.1007/s00439-006-0135-z. Epub 2006 Feb 17.

    PMID: 16485136BACKGROUND

  • Brinton LA, Sakoda LC, Lissowska J, Sherman ME, Chatterjee N, Peplonska B, Szeszenia-Dabrowska N, Zatonski W, Garcia-Closas M. Reproductive risk factors for endometrial cancer among Polish women. Br J Cancer. 2007 May 7;96(9):1450-6. doi: 10.1038/sj.bjc.6603731. Epub 2007 Apr 10.

    PMID: 17426703BACKGROUND

MeSH Terms

Conditions

Ovarian NeoplasmsEndometrial NeoplasmsBreast NeoplasmsGonadal DisordersUterine Diseases

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesUterine NeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Montserrat Garcia-Closas, M.D.

    National Cancer Institute (NCI)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

September 1, 1999

Primary Completion

April 16, 2020

Study Completion

April 16, 2020

Last Updated

April 20, 2020

Record last verified: 2020-04

Locations

PL(2)