ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE

Brief Summary

Detailed Description

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.

Primary Outcomes

Secondary Outcomes

• Analysis of acquired genetic changes within DCIS