- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00445445
Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.
PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
OBJECTIVES:
- Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.
- Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.
- Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.
OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.
- Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
- Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.
Studietype
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
-
-
Ohio
-
Cleveland, Ohio, Forente stater, 44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
-
Mayfield Heights, Ohio, Forente stater, 44124
- UH-Monarch
-
Mentor, Ohio, Forente stater, 44060
- UH-LUICC
-
Middleburg Heights, Ohio, Forente stater, 44130
- UH-Southwest
-
Orange Village, Ohio, Forente stater, 44122
- UH-Chagrin Highlands Orange Village Ohio 44122
-
Sandusky, Ohio, Forente stater, 44870
- UH-Firelands
-
South Euclid, Ohio, Forente stater, 44121
- UH-Green Road
-
Westlake, Ohio, Forente stater, 44145
- UH-Westlake
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system
- Have at least 3 screening mammograms since 1994
- for cases, diagnosis with breast cancer between 2004-2006
Exclusion criteria:
- having had irregular screening (less than 3 mammorgrams since 1994)
- Having breast implants
- Known carriers of BRCA1/BRCA2 genes
- Unable to give written consent
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
---|---|
Patients
Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
|
Urine samples will be assessed for levels of bisphenol-A
Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history.
This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
|
Healthy participants
Healthy participant who is receiving routine medical care (e.g., screening mammograms.
Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
|
Urine samples will be assessed for levels of bisphenol-A
Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history.
This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.
Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
Tidsramme: cancer cases diagnosed within the last 3 years (2004-2006).
|
cancer cases diagnosed within the last 3 years (2004-2006).
|
Patterns of within-individual longitudinal change in MD
Tidsramme: cancer cases diagnosed within the last 3 years (2004-2006)
|
cancer cases diagnosed within the last 3 years (2004-2006)
|
Predictors of across-individual differences in MD change
Tidsramme: cancer cases diagnosed within the last 3 years (2004-2006)
|
cancer cases diagnosed within the last 3 years (2004-2006)
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CASE1105 (Annen identifikator: Case Comprehensive Cancer Center)
- P30CA043703 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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