Actively Recruiting
EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
Led by Thomas Jefferson University · Updated on 2026-03-17
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the link between social factors, known as Social Determinants of Health (SDoH), and inflammation in women diagnosed with breast cancer or ductal carcinoma in situ. This observational pilot study aims to understand how these social factors relate to inflammation levels, which can influence cancer progression. The study uses validated surveys and blood samples to explore these connections in breast cancer patients who have not yet started therapy. Participants will complete the Centers for Medicare and Medicaid Services (CMS) survey assessing social needs like housing, food, and safety, along with a distress screening tool developed by the National Comprehensive Cancer Network. Blood samples will be collected to measure inflammation markers such as IL-6 and other immune molecules. Additional data like weight, body composition, and diet recall will also be gathered to build a detailed molecular signature related to inflammation. Participation involves a single visit where patients fill out questionnaires and provide a blood sample. Researchers will analyze the relationship between social factors and inflammation markers, as well as assess psychosocial complications and immune function. The total participation time is brief, focusing on one-time sample collection and survey completion, with the goal of improving understanding of how social factors impact breast cancer biology.
CONDITIONS
Brief Title
EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female
- 18 years of age or older at time of consent
- Biopsy proven invasive breast cancer or ductal carcinoma in situ
- Has not yet received cancer therapy for breast cancer diagnosis
- ECOG Performance Status less than 2
- Able to provide consent
- Must be English speaking
You will not qualify if you...
- Started therapy or had definitive oncologic breast cancer surgery
- Another malignancy within the past 6 months except non-melanomatous skin lesion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants complete surveys and provide blood samples to assess social determinants of health, distress levels, diet, and biomarkers related to inflammation and immune function.
1 visit (in-person)
Duration - Up to 1 year
Participants' patient characteristics such as weight, body composition, and outcomes are monitored over time to understand the relationship between social determinants and inflammation.
Follow-up assessments may occur as per study schedule
Trial Site Locations
Total: 1 location
1
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
Research Team
N
Nicole Simone, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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