Breast Cancer
Conditions
Keywords
ductal breast carcinoma in situ
Brief summary
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.
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.
Interventions
GENETICDNA analysis
GENETICpolymorphism analysis
GENETICprotein analysis
OTHERlaboratory biomarker analysis
OTHERquestionnaire administration
OTHERsurvey administration
Sponsors
Queen Mary University of London
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
DISEASE CHARACTERISTICS: * Prior or current diagnosis of pure ductal carcinoma in situ (DCIS) * Age ≤ 60 years at the time of diagnosis * DCIS with contralateral synchronous or asynchronous invasive breast cancer is permitted * DCIS associated with microinvasion (foci \< 1 mm) is permitted * Healthy age- and ethnicity-matched controls * No history of DCIS * No relative (up to second degree) diagnosed with DCIS PATIENT CHARACTERISTICS: * Not specified PRIOR CONCURRENT THERAPY: * Not specified
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Collection of blood and/or tumor tissue | — |
| Frequency of genetic variants that predispose women to develop ductal carcinoma in situ (DCIS) | — |
| Effect of these variants on tumor risk | — |
| Benefit of testing for these variants | — |
Secondary
| Measure | Time frame |
|---|---|
| Analysis of acquired genetic changes within DCIS | — |
Countries
United Kingdom
Outcome results
None listed