Ovarian NeoplasmsNCT00341458
Breast Cancer in Poland: An Expanded Study to Assess Occupational and Environmental Factors and Interactions With Genetics
An observational study of Ovarian Neoplasms and Endometrial Neoplasms, run by National Cancer Institute (NCI) at 2 sites in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 74 years, women only
- Conditions the study is for
- Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms
- How many people
- 6,086 participants
- Where
- 2 sitesPoland
- Study dates
- 1 Sep 1999to 16 Apr 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
None listed.
Trial locations and contacts
2 sites in 1 country.
Poland2 sites
Nofer Institute of Occupational Medicine
Lodz
Maria Sklodowska Curie Memorial Cancer Center and Institute of Oncology
Warsaw
About this study
Official title: 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)....
Read the 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.
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms, Gonadal Disorders, Uterine Diseases
- Keywords
- Breast Cancer, Environment, Genetics, Epidemiology
- Medical subject headings
- Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms, Gonadal Disorders, Uterine Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast cancer
Pathologically confirmed diagnosis of breast cancer
Measured: incident
Ovarian cancer
Pathologically confirmed diagnosis of ovarian cancer
Measured: incident
Endometrial cancer
Pathologically confirmed diagnosis of endometrial cancer
Measured: incident
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2006 (estimated)
- Study start1 Sep 1999
- Primary completion16 Apr 2020
- Study completion16 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Ovarian NeoplasmsStudies of the same condition, open and under way.
- More trials run by National Cancer Institute (NCI)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 6,086 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute (NCI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Montserrat Garcia-Closas, M.D., Principal investigator, National Cancer Institute (NCI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00341458
- Sponsor's protocol ID
- 999999040
- Other IDs
- OH99-C-N040
- Status last verified
- Apr 2020
- First submitted
- 19 Jun 2006
- Last updated
- 20 Apr 2020
- Results posted
- No
Publications
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.
PubMed 16755295Garcia-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.
PubMed 17411440Garcia-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.
PubMed 16485136Brinton 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.
PubMed 17426703
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast, Ovarian and Endometrial Cancer Case-Control Study in Poland
- ClinicalTrials.gov ID
- NCT00341458
- Acronym / sponsor ID
- 999999040
- Conditions
- Ovarian Neoplasms, Endometrial Neoplasms, Breast Neoplasms, Gonadal Disorders, Uterine Diseases
- Keywords
- Breast Cancer, Environment, Genetics, Epidemiology
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 6,086 participants (actual)
- Lead sponsor
- National Cancer Institute (NCI)US National Institutes of Health
- Study start
- 1 Sep 1999 (actual)
- Primary completion
- 16 Apr 2020 (actual)
- Study completion
- 16 Apr 2020 (actual)
- First posted
- 21 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Breast cancer
Time frame: incident
Pathologically confirmed diagnosis of breast cancer
Ovarian cancer
Time frame: incident
Pathologically confirmed diagnosis of ovarian cancer
Endometrial cancer
Time frame: incident
Pathologically confirmed diagnosis of endometrial cancer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
- Background: PubMed 16755295Garcia-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.
- Background: PubMed 17411440Garcia-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.
- Background: PubMed 16485136Garcia-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.
- Background: PubMed 17426703Brinton 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Montserrat Garcia-Closas, M.D. principal investigator
National Cancer Institute (NCI)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ovarian Neoplasms and Endometrial Neoplasms, run by National Cancer Institute (NCI) at 2 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast cancer (time frame: incident). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00341458, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.