Recruiting

Observational Study

Sponsor:

Thomas Jefferson University

Code:

NCT07478016

Conditions

Breast Cancer

Ductal Carcinoma In Situ

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Survey Assessments

Diet Recall

Blood Biomarker Collection

Study Details

Brief summary:

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.

Conditions

Breast Cancer

Ductal Carcinoma In Situ

Study ID

NCT07478016

Start date

Dec 21, 2022

Status verified date

Mar, 2026

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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

Interventions

Survey Assessments

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

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

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

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 and Locations

Central contacts

Nicole Simone, MD

215-955-6702Nicole.Simone@jefferson.edu

Locations

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Nicole Simone, MD

215-955-6702Nicole.Simone@jefferson.edu

More Information

Sponsor

Thomas Jefferson University

Last update posted

Mar 17, 2026

Last verified

Mar, 2026

Keywords

  • Social Determinants of Health
  • IL-6
  • cytokine profile
  • immune marker profile

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Thomas Jefferson University on 2026-03-17.