EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Thomas Jefferson University
Study ID
NCT07478016
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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
  • Blood Biomarker Collection — OTHER
    The blood specimens will be processed for plasma and buffy coat.

Study Details

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.

Key Dates

Start date
Dec 21, 2022
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
200 participants (estimated)

Arms

  • Arm: EXIST Cohort
    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

Primary Outcome Measure

Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation [ Time Frame: At Visit 1 (1 day) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Nicole Simone, MD
[email protected]
215-955-6702

Find similar trials in Philadelphia, PA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University· Philadelphia, PA

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