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NCT Number: NCT07478016

EXploring Inflammation and Social deTerminants 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.

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Key information

Conditions

Breast Cancer Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Ductal Carcinoma in Situ Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location status: Recruiting

Location contact

Nicole Simone, MD

CONTACT

[email protected]

215-955-6702

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
  • Female
  • >18 years old at time of consent
  • Biopsy proven invasive breast cancer or ductal carcinoma in situ
  • Candidate has not yet received cancer therapy for their breast cancer diagnosis
  • ECOG Performance Status < 2
  • Able to provide consent
  • Must be English speaking

Exclusion criteria

  • An individual who meets any of the following criteria will be excluded from participation in this study:
  • Patient has started therapy or already had definitive oncologic surgery
  • Another malignancy within the past 6 months that was not a non-melanomatous skin lesion

Treatment and study plan

Survey Assessments

Other

The CMS Social Determinant of Health (SDOH) Survey refers to CMS's standardized screening tool used to identify patient needs related to housing, food, transportation, utilities, and safety. It helps providers address non-medical barriers to care and improve health outcomes by documenting social risk factors in a consistent manner.

The NCCN Distress Thermometer and Problem List is a screening tool developed by the National Comprehensive Cancer Network (NCCN) to help identify and assess distress in people with cancer. It includes a 0-10 distress rating scale and a Problem List that allows patients to indicate specific practical, emotional, physical, social, and spiritual concerns contributing to their distress.

Other names: Centers for Medicare and Medicaid Services (CMS) survey, CMS Survey, NCCN Distress Thermometer and Problem List, National Comprehensive Cancer Network Distress Thermometer and Problem List

Diet Recall

Other

A diet recall is a nutrition assessment method where an individual reports all foods and beverages consumed over a specific period, most commonly the previous 24 hours. It captures detailed information-such as portion sizes, preparation methods, and timing-to help clinicians or researchers evaluate dietary intake and identify nutritional patterns or deficiencies

Other names: Food Diary

Blood Biomarker Collection

Other

The blood specimens will be processed for plasma and buffy coat.

Other names: Blood/Plasma Sample

Primary outcomes

  1. Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation

    Time frame: At Visit 1 (1 day)

    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. Levels of IL-6 will be measured and this will be used as a surrogate for inflammation.

Secondary outcomes

  1. At-Risk Patients Identified for Illness-Related Psychosocial Complications

    Time frame: At Visit 1 (1 day)

    The National Comprehensive Cancer Network Distress Thermometer (NCCN Distress Thermometer) and Problem List will be used to identify patients with illness-related psychological complications. NCCN Distress Thermometer is a screening tool used to quickly assess psychological distress in patients with cancer. It consists of a single-item scale where patients rate their distress over the past week on a 0-10 scale, with 0 = No distress and 10 = Extreme distress. Higher scores indicate worse outcomes (greater distress), while lower scores indicate less distress.

  2. Cytokine Profiling

    Time frame: At Visit 1 (1 day)

    Using a LP-compliant Quantibody® Multiplex ELISA platform, 200 analytes including Il-6, will be evaluated on plasma before and after diet to include: cytokines, growth factors, proteases, and soluble receptors. After determining statistically significant alterations, GO Pathway analysis will be performed.

    It is expected that Sparse Principal Component Analysis (SPCA) of these 200 analytes will reveal a small subset (up to ~10 cytokines) and their linear combination that provides a more precise measure of systemic inflammation than IL-6 alone. This composite biomarker will serve as a secondary endpoint in the clinical trial proposed in Project 2C.

  3. Immune Function

    Time frame: At Visit 1 (1 day)

    Flow cytometry will be performed to characterization anti-tumor immunity (CD8 T-cells: CD3+CD8+, PD-1), T-cell activation (IFNɣ+), and an immune suppressive environment (Treg as per CD25+FOXP3+).

Study contacts

Contact information is provided by the study sponsor or research team.

Nicole Simone, MD

CONTACT

[email protected]

215-955-6702

Sponsors and collaborators

Lead sponsor

Thomas Jefferson University

Other

Registry information

Official study title

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

Acronym: EXIST

Important dates

Study start
2022
Primary completion
2027
Study completion
2028
First posted
Mar 17, 2026
Registry last updated
Mar 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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