Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
10 februari 2020 uppdaterad av: Case Comprehensive Cancer Center
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.
Studieöversikt
Status
Avslutad
Betingelser
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Faktisk)
2201
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Ohio
-
Cleveland, Ohio, Förenta staterna, 44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
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Mayfield Heights, Ohio, Förenta staterna, 44124
- UH-Monarch
-
Mentor, Ohio, Förenta staterna, 44060
- UH-LUICC
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Middleburg Heights, Ohio, Förenta staterna, 44130
- UH-Southwest
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Orange Village, Ohio, Förenta staterna, 44122
- UH-Chagrin Highlands Orange Village Ohio 44122
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Sandusky, Ohio, Förenta staterna, 44870
- UH-Firelands
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South Euclid, Ohio, Förenta staterna, 44121
- UH-Green Road
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Westlake, Ohio, Förenta staterna, 44145
- UH-Westlake
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
40 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Testmetod
Sannolikhetsprov
Studera befolkning
Breast cancer cases diagnosed after 1994 and equal number of frequency-matched (by age within 2 years and ethnicity) controls.
Cases and eligible controls with at least 3 screening mammograms since 1994 will be recruited through the University Hospitals Breast Center, and primary care clinics within the University Hospitals Health System (UHHS).
The restriction of 3 or more screening mammograms will allow us to adequately model the longitudinal change patterns.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
Tidsram: 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
Tidsram: 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
Tidsram: cancer cases diagnosed within the last 3 years (2004-2006)
|
cancer cases diagnosed within the last 3 years (2004-2006)
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
10 januari 2007
Primärt slutförande (Faktisk)
21 juli 2014
Avslutad studie (Faktisk)
21 juli 2014
Studieregistreringsdatum
Först inskickad
7 mars 2007
Först inskickad som uppfyllde QC-kriterierna
7 mars 2007
Första postat (Uppskatta)
9 mars 2007
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
11 februari 2020
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 februari 2020
Senast verifierad
1 februari 2020
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- CASE1105 (Annan identifierare: Case Comprehensive Cancer Center)
- P30CA043703 (U.S.S. NIH-anslag/kontrakt)
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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