About this trial
This study evaluates the association of dietary inflammatory potential with breast cancer risk. Information collected in this study may help doctors to identify modifiable risk factors, screen high risk patients early, improve prevention strategies, and provide timely intervention for early therapeutic management as needed.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age >= 18 years
Established in the high risk clinic at OSUCCC- James (includes patients with family history of breast cancer [BC], known genetic predisposition, personal history of known atypia/breast lobular carcinoma in situ [LCIS], or prior chest wall radiation)
Patients at high risk for BC established in the surgical oncology clinic at Stefanie Spielman Comprehensive Breast Center (SSCBC), with one of the following diagnoses: Atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), lobular carcinoma in situ (LCIS), sclerosing adenosis (SA), or radial scars (RS)
Able to read and understand English
Disqualifiers
Prisoners
Not able to speak and understand English
Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC
Trial population
Patients at high risk for breast cancer
Trial design
Cohort
Prospective
Treatments tested in this trial
Follow-Up
Procedure/SurgeryUndergo follow up
Physical Examination
Procedure/SurgeryComplete physical measurements
Questionnaire Administration
Other interventionComplete questionnaires
Treatment groups
Trial outcomes
Primary outcomes
Time to breast cancer events during study follow up
Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables). To assess the association of baseline Empirical Dietary Inflammatory pattern (EDIP) scores with breast cancer incidence, Cox proportional hazards regression will be used to estimate the hazard ratio (HR) and its 95% confidence interval (CI).
Secondary outcomes
Bone marrow index
Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Waist-hip ratio
Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Waist circumference
Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Mammographic breast density
Will be measured by breast imaging reporting and data system. Will be expressed as the means, medians and standard deviations (for continuous variables) or frequencies and percentages (for categorical variables).
Other outcomes
Proportion of patients who received at least 1 supplemental screening breast by breast magnetic resonance imaging, automated breast ultrasound, and contrasted-enhanced spectral mammography during study follow up
Proportion of patients initiating chemoprevention during study follow up
Proportion of patients initiating chemoprevention within 12 months of enrollment will be summarized.
Sponsors and contacts
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