• Collection of blood and/or tumor tissue [ Designated as safety issue: No ]
  
• Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS) [ Designated as safety issue: No ]
  
• Effect of these variants on tumor risk [ Designated as safety issue: No ]
  
• Benefit of testing for these variants [ Designated as safety issue: No ]
  

• Analysis of acquired genetic changes within DCIS [ Designated as safety issue: No ]
  

OBJECTIVES:

Primary

• To collect blood and/or tumor tissue of patients with ductal breast carcinoma in situ (DCIS) and their age- and ethnicity-matched controls to identify the inherited variation that predisposes women to develop DCIS.
• To determine the frequency of these variants.
• To determine the effect of these variants on tumor risk.
• To determine the benefit of testing for these variants in the clinical setting so that those at higher risk could be identified, counseled, and screened.

Secondary

• To analyze the acquired genetic changes within DCIS to identify which cases are more likely to develop invasive disease.

OUTLINE: This is a multicenter study.

All participants complete a questionnaire to collect their family history, a brief medical history, and epidemiological data.

Patients undergo collection of blood and/or tumor tissue samples; DNA is extracted for genotyping, comparison of allele and genotype frequencies (polymorphisms), genetic profiling, DNA analysis, and protein analysis. Histopathology reports are also collected. Healthy volunteers undergo collection of blood samples.

PROJECTED ACCRUAL: A minimum of 3,000 patients and 3,000 controls will be accrued for this study.