How social factors relate to inflammation in women with breast cancer.
Official title: EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
Run by Thomas Jefferson University · NCT07478016 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 200 (estimated) |
| Sponsor | Thomas Jefferson University Academic / other |
| Locations | 1 site (Philadelphia, Pennsylvania) |
| Status | Recruiting |
| Started | December 21, 2022 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2028 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT07478016 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.