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NCT00341458

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

Completed Last updated 20 April 2020
What this trial tests

trial in Ovarian Neoplasms in 6,086 participants. Completed in 16 April 2020.

Timeline
1 September 1999
Primary endpoint
16 April 2020
16 April 2020

Quick facts

Lead sponsorNational Cancer Institute (NCI)
StatusCompleted
Study typeOBSERVATIONAL
Enrollment6,086
Start date1 September 1999
Primary completion16 April 2020
Estimated completion16 April 2020
Sites2 locations across Poland

Conditions studied

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 20 to 74, female only, with Ovarian Neoplasms or Endometrial Neoplasms. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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)....

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Pharmacometabolomics reveals urinary diacetylspermine as a biomarker of doxorubicin effectiveness in triple negative breast cancer.
    Velenosi TJ, Krausz KW, Hamada K, Dorsey TH, et al · · 2022 · cited 11× · PMID 36207498 · DOI 10.1038/s41698-022-00313-4

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Other recruiting trials for Ovarian Neoplasms

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00341458.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing