What this study is
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.
What's being tested
- Survey Assessments
Intervention · 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
Intervention · 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
Intervention · OTHER
The blood specimens will be processed for plasma and buffy coat.
Study details
- Official title
- EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
- Sponsor
- Thomas Jefferson University
- Conditions
- Breast Cancer · Ductal Carcinoma In Situ
- Enrolling
- 200 people
- Starts
- 2022-12-21
- Est. completion
- 2028-12-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openSidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, United States
- Nicole Simone, MD · Contact215-955-6702Nicole.Simone@jefferson.edu
Recruiting
Study team
Sponsor
Thomas Jefferson University
Study ID 22D.611
Principal investigator
Nicole Simone, MD
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.