EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients

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 local Philadelphia population, the investigators chose to add several questions to understand potential social isolation. Levels of IL-6 will be measured and this will be used as a surrogate for inflammation.

SECONDARY:

Patient characteristics such as weight, body composition, food recall and outcomes will be monitored. Additionally, members of the IGF-1R-AKT pathway, IL1β, and insulin in the plasma , will be assessed to create a molecular signature of response to this therapy.

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