How social factors relate to inflammation in women with breast cancer.
EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
This pilot will try to link social and economic factors to blood markers of inflammation in women newly diagnosed with breast cancer who have not yet started treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Trial ID | NCT07478016 on ClinicalTrials.gov |
What this trial studies
This is a single-visit, observational pilot enrolling English-speaking women with biopsy-proven invasive breast cancer or DCIS who have not begun cancer therapy. Participants complete validated Social Determinants of Health and distress questionnaires (CMS-based plus added social isolation items), a diet recall, and provide a plasma/buffy coat blood sample and basic body measurements. Lab testing will measure IL-6 as a primary inflammation marker and a broader panel including IL-1β, insulin, and members of the IGF-1R–AKT pathway to define an immune/metabolic signature. The study aims to correlate questionnaire-derived SDoH scores with circulating biomarker levels to characterize links between social adversity and inflammation at diagnosis.
Who should consider this trial
Good fit: Women over age 18 with biopsy-proven invasive breast cancer or ductal carcinoma in situ who have not yet received cancer therapy, have ECOG <2, and can consent in English.
Not a fit: Patients who have already started cancer treatment, have a recent other malignancy, or cannot complete English-language questionnaires are unlikely to benefit from this single-visit biomarker correlation effort.
Why it matters
Potential benefit: If successful, the results could identify patients whose social needs are tied to biological inflammation and help target supportive interventions to improve outcomes.
How similar studies have performed: Prior research has linked social adversity and higher IL-6 or inflammatory profiles in other populations and some cancer cohorts, but applying the CMS SDoH survey with this specific biomarker panel in newly diagnosed breast cancer is largely exploratory.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Individuals must meet all the following inclusion criteria to be eligible to participate in the study: 1. Female 2. \>18 years old at time of consent 3. Biopsy proven invasive breast cancer or ductal carcinoma in situ 4. Candidate has not yet received cancer therapy for their breast cancer diagnosis 5. ECOG Performance Status \< 2 6. Able to provide consent 7. Must be English speaking Exclusion Criteria: * An individual who meets any of the following criteria will be excluded from participation in this study: 1. Patient has started therapy or already had definitive oncologic surgery 2. Another malignancy within the past 6 months that was not a non-melanomatous skin lesion
Where this trial is running
Philadelphia, Pennsylvania
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Simone, MD — Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Study coordinator: Nicole Simone, MD
- Email: Nicole.Simone@jefferson.edu
- Phone: 215-955-6702
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.