Evaluating how diet affects breast cancer risk
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
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 |
|---|---|
| Enrollment | 960 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ohio State University Comprehensive Cancer Center Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Columbus, Ohio) |
| Trial ID | NCT05178498 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with a known history of ductal carcinoma in situ or invasive breast cancer will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Columbus, Ohio
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.