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| ID | Type | Description | Link |
|---|---|---|---|
| JT 20452 | Other Identifier | JeffTrial Number |
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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.
OBJECTIVE:
To understand the link between adverse Social Determinants of Health (SDoH) on inflammation, a known contributor to cancer progression and metastases.
PRIMARY:
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. SDoH will be evaluated as per the Centers for Medicare and Medicaid Services (CMS) survey. This survey was chosen due to the documented validity of the questions based on the literature backing each question, the scoring system that accompanies it and the questions relationship with health outcomes. Based on the local Philadelphia population, the investigators chose to add several questions to understand potential social isolation. Levels of IL-6 will be measured and this will be used as a surrogate for inflammation.
SECONDARY:
Patient characteristics such as weight, body composition, food recall and outcomes will be monitored. Additionally, members of the IGF-1R-AKT pathway, IL1β, and insulin in the plasma , will be assessed to create a molecular signature of response to this therapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
Exclusion Criteria:
An individual who meets any of the following criteria will be excluded from participation in this study:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicole Simone, MD | Contact | 215-955-6702 | Nicole.Simone@jefferson.edu |
| Name | Affiliation | Role |
|---|---|---|
| Nicole Simone, MD | Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University | Recruiting | Philadelphia | Pennsylvania | 19107 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D015337 | Multicenter Studies as Topic |
| D006278 | Medicare |
| C114545 | CD2-associated protein |
| D011795 | Surveys and Questionnaires |
| D015930 | Diet Records |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D016020 | Epidemiologic Study Characteristics |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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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.
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| 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 |
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| Blood Biomarker Collection | Other | The blood specimens will be processed for plasma and buffy coat. |
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| At Visit 1 (1 day) |
| 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. | At Visit 1 (1 day) |
| 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+). | At Visit 1 (1 day) |
| D017437 |
| Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D008483 | Medical Assistance |
| D011632 | Public Assistance |
| D005380 | Financing, Government |
| D005381 | Financing, Organized |
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D007348 | Insurance, Health |
| D007341 | Insurance |
| D007878 | Legislation as Topic |
| D012926 | Social Control, Formal |
| D003625 | Data Collection |
| D011996 | Records |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |