EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorThomas Jefferson University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
200 women over the age of 18 with an ECOG score \< 2 with a biopsy proven invasive breast cancer or ductal carcinoma in situ of the breast who are candidates for definitive breast cancer surgery.
Trial design
Design model
Cohort
Time perspective
Cross-sectional
Treatments tested in this trial
Survey Assessments
Other interventionThe 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.
Diet Recall
Other interventionA 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
Blood Biomarker Collection
Other interventionThe blood specimens will be processed for plasma and buffy coat.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: EXIST Cohort3 interventions
Trial outcomes
Primary outcomes
1
Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation
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.
Time frame
At Visit 1 (1 day)Secondary outcomes
1
At-Risk Patients Identified for Illness-Related Psychosocial Complications
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.
Time frame
At Visit 1 (1 day)2
Cytokine Profiling
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.
Time frame
At Visit 1 (1 day)3
Immune Function
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+).
Time frame
At Visit 1 (1 day)Sponsors and contacts
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Source ClinicalTrials.gov