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Clinical Trial Summary

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.


Clinical Trial Description

PRIMARY OBJECTIVE: I. To evaluate the association of dietary inflammatory potential (measured by Empirical Dietary Inflammatory Pattern [EDIP] score) at baseline using Diet History Questionnaire III (DHQIII) food frequency questionnaire (FFQ) with the incidence of breast cancer in high risk women established in the breast cancer prevention clinic at Ohio State University Comprehensive Cancer Center (OSUCCC) - James. SECONDARY OBJECTIVES: I. To evaluate changes in inflammatory potential of diet (EDIP score) from baseline FFQ and subsequently administered annually, and determine how these dietary changes relate to breast cancer risk longitudinally. II. To evaluate associations of dietary inflammatory potential (EDIP score) with measures of obesity including bone marrow index (BMI) (obesity defined as >= 30, non-obese < 30) and abdominal/visceral adiposity (waist-hip ratio [WHR] > 0.85 or waist circumference [WC] >= 80 cm in women) at baseline. III. To evaluate the association of dietary inflammatory potential (EDIP score) with mammographic breast density by breast imaging reporting and data system (BIRADS) classification at baseline. CORRELATIVE OBJECTIVES: I. To evaluate the correlation of baseline and annual inflammatory blood-based biomarkers (IL-6, hsCRP, adiponectin, leptin, insulin resistance [Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)]) with: a) dietary inflammatory potential (EDIP score) and b) visceral adiposity (waist-hip ratio > 0.85 or waist circumference >= 80 cm in women) and c) mammographic breast density by BIRADS classification at baseline and longitudinally (every year for 5 years). II. To evaluate the association of baseline circulating biomarkers (hsCRP, TNF-a, insulin resistance [HOMA-IR]) and breast cancer incidence longitudinally in high risk patients. EXPLORATORY OBJECTIVES: I. Describe utilization of supplemental imaging by type, including breast magnetic resonance imaging (MRI), automated breast ultrasound (ABUS) and contrasted-enhanced spectral mammography (CESM), in all enrolled women. II. Describe use of chemoprevention strategies (initiation of tamoxifen, raloxifene, aromatase inhibitor (AI), or other) in women presenting at the high risk clinic at OSUCCC-James. OUTLINE: Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05178498
Study type Observational
Source Ohio State University Comprehensive Cancer Center
Contact The Ohio State University Comprehensive Cancer Center
Phone 800-293-5066
Email [email protected]
Status Not yet recruiting
Phase
Start date March 1, 2022
Completion date December 31, 2024

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