Recruiting

Observational Study

Sponsor:

Ohio State University Comprehensive Cancer Center

Code:

NCT05178498

Conditions

Breast Atypical Ductal Hyperplasia

Breast Atypical Lobular Hyperplasia

Breast Carcinoma

Breast Lobular Carcinoma In Situ

Breast Sclerosing Adenosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Follow-Up

Physical Examination

Questionnaire Administration

Study Details

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

Study ID

NCT05178498

Start date

Oct 25, 2023

Status verified date

Jun, 2026

Completion date

Dec 31, 2035

Anticipated

Primary completion date

Dec 31, 2035

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

960 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Follow-Up

Undergo follow up

Physical Examination

Complete physical measurements

Questionnaire Administration

Complete questionnaires

Primary outcome measure

  • Time to breast cancer events during study follow up [ Time Frame: Up to 10 years ]

Central Contacts and Locations

Central contacts

The Ohio State University Comprehensive Cancer Center

800-293-5066OSUCCCClinicaltrials@osumc.edu

Locations

Ohio State University Comprehensive Cancer Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Sagar D. Sardesai, MSPH, PhD

614-293-6401Sagar.Sardesai@osumc.edu

Principal Investigator:

Sagar D. Sardesai, MSPH, PhD

More Information

Sponsor

Ohio State University Comprehensive Cancer Center

Last update posted

Jun 12, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center on 2026-06-12.