Observational Study on Diet and Breast Cancer Risk

This study is looking at how your diet's inflammatory potential might affect your risk of developing breast cancer. Researchers want to understand if certain eating patterns, measured by a score called the Empirical Dietary Inflammatory Pattern (EDIP), are linked to conditions like atypical ductal hyperplasia (unusual cell growth in milk ducts) or breast cancer itself. By collecting information through questionnaires and physical exams over up to 10 years, this study aims to identify modifiable risk factors. This could help doctors improve prevention strategies and provide earlier care for people at high risk for breast cancer. The study is observational, meaning you won't receive any specific interventions, but your health information will be followed.

Study design
This is an observational study planning to enroll 960 participants. It is not a randomized trial and does not specify a phase.
What's involved
You would undergo follow-up appointments, complete physical measurements, and fill out questionnaires over a period of up to 10 years.
Compensation
Not stated in the trial record.
Follow-up
You will be followed for breast cancer events for up to 10 years during the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05178498

Impact of Dietary Inflammatory Potential on Breast Cancer Risk

Recruiting
Not specifiedAges 18+Observational
Ohio State University Comprehensive Cancer Center
~960 participants
Updated 2026-06-12 on ClinicalTrials.gov
What's tested:Follow-UpPhysical ExaminationQuestionnaire Administration

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Time to breast cancer events during study follow up
Measured over Up to 10 years
Breast Atypical Ductal Hyperplasia
Breast Atypical Lobular Hyperplasia
Breast Carcinoma
Breast Lobular Carcinoma In Situ
Breast Sclerosing Adenosis
1 sites across 1 states
Ohio1
  • Sagar D Sardesai, MSPH, PhD · PRINCIPAL_INVESTIGATOR · Ohio State University Comprehensive Cancer Center
The Ohio State University Comprehensive Cancer Center
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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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
Able to provide informed consent
Must consent to continued follow-up of medical records during the study period

Exclusion

Prisoners
Not able to speak and understand English
Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC
  • Time to breast cancer events during study follow upUp to 10 years

    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).