Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
10 de febrero de 2020 actualizado por: 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.
Descripción general del estudio
Estado
Terminado
Condiciones
Descripción detallada
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.
Tipo de estudio
De observación
Inscripción (Actual)
2201
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
-
-
Ohio
-
Cleveland, Ohio, Estados Unidos, 44106-5065
- University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
-
Mayfield Heights, Ohio, Estados Unidos, 44124
- UH-Monarch
-
Mentor, Ohio, Estados Unidos, 44060
- UH-LUICC
-
Middleburg Heights, Ohio, Estados Unidos, 44130
- UH-Southwest
-
Orange Village, Ohio, Estados Unidos, 44122
- UH-Chagrin Highlands Orange Village Ohio 44122
-
Sandusky, Ohio, Estados Unidos, 44870
- UH-Firelands
-
South Euclid, Ohio, Estados Unidos, 44121
- UH-Green Road
-
Westlake, Ohio, Estados Unidos, 44145
- UH-Westlake
-
-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
40 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
Sí
Géneros elegibles para el estudio
Femenino
Método de muestreo
Muestra de probabilidad
Población de estudio
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.
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
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.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
Within-individual mammographic density (MD) longitudinal change and breast cancer risk
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: cancer cases diagnosed within the last 3 years (2004-2006)
|
cancer cases diagnosed within the last 3 years (2004-2006)
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cheryl Thompson, PhD, University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
10 de enero de 2007
Finalización primaria (Actual)
21 de julio de 2014
Finalización del estudio (Actual)
21 de julio de 2014
Fechas de registro del estudio
Enviado por primera vez
7 de marzo de 2007
Primero enviado que cumplió con los criterios de control de calidad
7 de marzo de 2007
Publicado por primera vez (Estimar)
9 de marzo de 2007
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de febrero de 2020
Última actualización enviada que cumplió con los criterios de control de calidad
10 de febrero de 2020
Última verificación
1 de febrero de 2020
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CASE1105 (Otro identificador: Case Comprehensive Cancer Center)
- P30CA043703 (Subvención/contrato del NIH de EE. UU.)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .