Clinical trial Recruiting at 1 site Observational Ages 18 and up

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 typeObservational
Ages18 Years and up
SexAll
Enrollment960 (estimated)
SponsorOhio State University Comprehensive Cancer Center
Academic / other
Drugs / interventionsradiation
Locations1 site (Columbus, Ohio)
StatusRecruiting
StartedOctober 25, 2023
Main results expectedDecember 31, 2035
Study endsDecember 31, 2035
Registry record updatedJune 12, 2026
Trial IDNCT05178498 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.