EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

NCT07478016 | Recruiting

• 2 other identifiers: 22D.611JT 20452
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

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.

  At Visit 1 (1 day)

Secondary Outcomes (3)

• At-Risk Patients Identified for Illness-Related Psychosocial Complications

  At Visit 1 (1 day)

• Cytokine Profiling

  At Visit 1 (1 day)

• Immune Function

  At Visit 1 (1 day)

Study Arms (1)

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

Other: Survey Assessments; Other: Diet Recall; Other: Blood Biomarker Collection

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.

Also known as: 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

EXIST Cohort

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

Also known as: Food Diary

EXIST Cohort

Blood Biomarker Collection OTHER

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

Also known as: Blood/Plasma Sample

EXIST Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You 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 may not qualify if:

• 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

Sponsors & Collaborators

• Thomas Jefferson University: lead

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood specimens collected at a single study visit will be processed for plasma and buffy coat. Venipuncture will be performed and PBMC's and plasma will be collected.

MeSH Terms

Conditions

Breast Neoplasms; Carcinoma, Intraductal, Noninfiltrating

Interventions

Multicenter Studies as Topic; Medicare; CD2-associated protein; Surveys and Questionnaires; Diet Records; Blood Specimen Collection

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Epidemiologic Study Characteristics; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Medical Assistance; Public Assistance; Financing, Government; Financing, Organized; Economics; Health Care Economics and Organizations; Insurance, Health; Insurance; Legislation as Topic; Social Control, Formal; Data Collection; Records; Organization and Administration; Health Services Administration; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Nicole Simone, MD

  Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicole Simone, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 17, 2026
• Study Start: December 21, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

US (1)