Breast Cancer Clinical Trial
Official title:
ICICLE- A Study to Investigate the genetiCs of In Situ Carcinoma of the ductaL subtypE
RATIONALE: Studying genes in samples of blood and/or tumor tissue from patients with cancer
may help doctors identify biomarkers related to cancer.
PURPOSE: This research study is looking at blood and/or tumor tissue samples from patients
with ductal carcinoma in situ and blood samples from healthy volunteers.
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.
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N/A
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