Evaluating how diet affects breast cancer risk
Official title: Longitudinal Study Evaluating the Impact of Dietary Inflammatory Potential on Breast Cancer Risk in a Cohort of Women Followed in the Breast Cancer Prevention Clinic at the Ohio State University Comprehensive Cancer Center- James Cancer Hospital and Solove Research Institute
Run by Ohio State University Comprehensive Cancer Center · NCT05178498 · Data updated 2026-11-12
This study is trying to see if the way women eat affects their risk of getting breast cancer, especially for those who are already at high risk.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 960 (estimated) |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbus, Ohio) |
| Status | Recruiting |
| Started | October 25, 2023 |
| Main results expected | December 31, 2035 |
| Study ends | December 31, 2035 |
| Registry record updated | June 12, 2026 |
| Trial ID | NCT05178498 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 18 and older who are established in a high-risk breast cancer clinic due to family history, genetic predisposition, or previous atypical breast conditions.
✕Probably not a fit
Patients with a known history of ductal carcinoma in situ or invasive breast cancer will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study investigates the link between dietary inflammatory potential and the risk of breast cancer in women identified as high risk at the Ohio State University Comprehensive Cancer Center. Participants will complete a food frequency questionnaire to assess their dietary inflammatory potential, which will be monitored over time to observe any changes and their relationship to breast cancer incidence. The study also aims to correlate dietary patterns with obesity measures and mammographic breast density. By identifying modifiable dietary risk factors, the research seeks to enhance prevention strategies and early intervention for breast cancer.
Why it matters
Potential benefit: If successful, this study could lead to improved dietary recommendations that may reduce breast cancer risk in high-risk women.
How similar studies have gone: While dietary impacts on cancer risk have been explored, this specific approach focusing on dietary inflammatory potential in high-risk breast cancer patients is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * Prisoners * Not able to speak and understand English * Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC
Where it's running
-
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States Recruiting
Study contacts
- Principal investigator: Sagar D Sardesai, MSPH, PhD — Ohio State University Comprehensive Cancer Center
- Study coordinator: The Ohio State University Comprehensive Cancer Center
- Email: OSUCCCClinicaltrials@osumc.edu
- Phone: 800-293-5066
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.