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EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

Sponsored by Thomas Jefferson University

About this study

This is a pilot trial to assess how measures of inflammation are correlated with Social Determinants of Health (SDoH) in breast cancer patients. Expected duration of subject participation is one single time point. The patients will fill out questionnaires and provide a plasma sample.

OBJECTIVE: To understand the link between adverse Social Determinants of Health (SDoH) on inflammation, a known contributor to cancer progression and metastases. PRIMARY: Patients with newly diagnosed, biopsy proven breast cancer will be screened for SDoH and distress via a distress screen and for biomarkers. The primary endpoint will be to understand the relationship between measured social determinants of health and inflammation as found in the plasma and buffy coat sample. SDoH will be evaluated as per the Centers for Medicare and Medicaid Services (CMS) survey. This survey was chosen due to the documented validity of the questions based on the literature backing each question, the scoring system that accompanies it and the questions relationship with health outcomes. Based on the lo…

Where this study is enrolling

  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    Philadelphia, Pennsylvania

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Who can participate

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

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Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.