Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

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.

Further Study Information

OBJECTIVES:

• Determine the 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.

• Determine 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 350 patients and 350 healthy participants will be accrued for this study.

Eligibility Criteria

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system AND meets the following criteria:

• Histologically confirmed breast cancer that was diagnosed between the years 2002-2004

• Known tumor stage

• Healthy participant who is receiving routine medical care (e.g., screening mammograms) at the University Hospitals Health System

• Underwent ≥ 4 prior screening mammograms at the Breast Center since 1994

• No known carriers of BRCA1 or BRCA2 genes

• Hormone receptor status:

• Known estrogen and/or progesterone receptor status

PATIENT CHARACTERISTICS:

• Female

• Menopausal status not specified

• No breast implants

PRIOR CONCURRENT THERAPY:

• Not currently taking tamoxifen citrate, raloxifene, or aromatase inhibitors

Trial Contact Information

Trial Lead Organizations/Sponsors

Case Comprehensive Cancer Center

Li Li

Principal Investigator

Cheryl Thompson

Principal Investigator

Li Li, MD, PhD		Ph: 216-844-3944
		Email: li.li@uhhospitals.org

U.S.A.
Ohio
	Cleveland
	Case Comprehensive Cancer Center
		Li Li, MD	Ph: 216-844-3944
			Email: li.li@uhhospitals.org
	Mayfield Heights
	UH-Monarch
	Mentor
	UH-LUICC
	Middleburgh Heights
	Southwest General Health Center
	Orange Village
	UHHS Chagrin Highlands Medical Center
	Sandusky
	University Hospitals Ireland Cancer Center at Firelands Regional Medical Center
	South Euclid
	UH-Green Road
	Westlake
	UH-Westlake

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00445445
Information obtained from ClinicalTrials.gov on August 02, 2012

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