Impact of Dietary Inflammatory Potential on Breast Cancer Risk

NCT05178498 | Recruiting

• 2 other identifiers: OSU-21065NCI-2021-03342
• Study Type: observational
• Target: 960
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Atypical Ductal Hyperplasia; Breast Atypical Lobular Hyperplasia; Breast Carcinoma; Breast Lobular Carcinoma In Situ; Breast Sclerosing Adenosis

Outcome Measures

Primary Outcomes (1)

• Time to breast cancer events during study follow up

  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).

  Up to 10 years

Secondary Outcomes (4)

• Bone marrow index

  Up to 10 years

• Waist-hip ratio

  Up to 10 years

• Waist circumference

  Up to 10 years

• Mammographic breast density

  Up to 10 years

Other Outcomes (2)

• Proportion of patients who received at least 1 supplemental screening breast by breast magnetic resonance imaging, automated breast ultrasound, and contrasted-enhanced spectral mammography during study follow up

  Up to 12 months

• Proportion of patients initiating chemoprevention during study follow up

  Up to 12 months

Study Arms (1)

Observational (physical exam, questionnaire)

Patients complete physical measurements every 6 months and complete questionnaires annually for 5 years. Patients are followed up annually in years 5-10.

Procedure: Follow-Up; Procedure: Physical Examination; Other: Questionnaire Administration

Interventions

Questionnaire Administration OTHER

Complete questionnaires

Observational (physical exam, questionnaire)

Follow-Up PROCEDURE

Undergo follow up

Also known as: Active Follow-up, Clinical Signs Follow-up, CLSFUP, Follow Up, follow_up, Followed, Followup

Observational (physical exam, questionnaire)

Physical Examination PROCEDURE

Complete physical measurements

Also known as: Assessment, General Examination, Physical, Physical Assessment, Physical Exam, physical_exam

Observational (physical exam, questionnaire)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients at high risk for breast cancer

You may qualify if:

• 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

You may not qualify if:

• Prisoners
• Not able to speak and understand English
• Known personal history of ductal carcinoma in situ (DCIS) or Invasive BC

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center: lead

Study Sites (1)

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

RECRUITING

Related Links

• The Jamesline

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms; Breast Carcinoma In Situ

Interventions

Chromatin Immunoprecipitation Sequencing; Follow-Up Studies; Restraint, Physical

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Chromatin Immunoprecipitation; Genetic Techniques; Investigative Techniques; High-Throughput Nucleotide Sequencing; Sequence Analysis; Sequence Analysis, DNA; Immunoprecipitation; Immunologic Techniques; Cohort Studies; Epidemiologic Studies; Epidemiologic Study Characteristics; Epidemiologic Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Control; Therapeutics; Immobilization

Study Officials

• Sagar D Sardesai, MSPH, PhD

  Ohio State University Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

The Ohio State University Comprehensive Cancer Center

CONTACT

800-293-5066; OSUCCCClinicaltrials@osumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2021
• First Posted: January 5, 2022
• Study Start: October 25, 2023
• Primary Completion (Estimated): December 31, 2035
• Study Completion (Estimated): December 31, 2035
• Last Updated: June 12, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)