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Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

10. Februar 2020 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

2201

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • Ohio
      • Cleveland, Ohio, Vereinigte Staaten, 44106-5065
        • University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
      • Mayfield Heights, Ohio, Vereinigte Staaten, 44124
        • UH-Monarch
      • Mentor, Ohio, Vereinigte Staaten, 44060
        • UH-LUICC
      • Middleburg Heights, Ohio, Vereinigte Staaten, 44130
        • UH-Southwest
      • Orange Village, Ohio, Vereinigte Staaten, 44122
        • UH-Chagrin Highlands Orange Village Ohio 44122
      • Sandusky, Ohio, Vereinigte Staaten, 44870
        • UH-Firelands
      • South Euclid, Ohio, Vereinigte Staaten, 44121
        • UH-Green Road
      • Westlake, Ohio, Vereinigte Staaten, 44145
        • UH-Westlake

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

40 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
Patients
Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Sonstiges: physiologic testing
Urine samples will be assessed for levels of bisphenol-A
Sonstiges: screening questionnaire administration
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.
Verfahren: breast imaging study
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.
Verfahren: radiomammography
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.
Verfahren: study of high risk factors
  • 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.
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.
Sonstiges: physiologic testing
Urine samples will be assessed for levels of bisphenol-A
Sonstiges: screening questionnaire administration
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.
Verfahren: breast imaging study
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.
Verfahren: radiomammography
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.
Verfahren: study of high risk factors
  • 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Zeitfenster
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: cancer cases diagnosed within the last 3 years (2004-2006)
cancer cases diagnosed within the last 3 years (2004-2006)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Case Comprehensive Cancer Center

Mitarbeiter

National Cancer Institute (NCI)

Ermittler

  • Hauptermittler: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

10. Januar 2007

Primärer Abschluss (Tatsächlich)

21. Juli 2014

Studienabschluss (Tatsächlich)

21. Juli 2014

Studienanmeldedaten

Zuerst eingereicht

7. März 2007

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

7. März 2007

Zuerst gepostet (Schätzen)

9. März 2007

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Februar 2020

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Februar 2020

Zuletzt verifiziert

1. Februar 2020

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • CASE1105 (Andere Kennung: Case Comprehensive Cancer Center)
  • P30CA043703 (US NIH Stipendium/Vertrag)

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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