Breast CancerEXISTNCT07478016
EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients
An observational study of Breast Cancer and Ductal Carcinoma In Situ, run by Thomas Jefferson University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Ductal Carcinoma In Situ
- What is being tested?
- Survey Assessments, Diet Recall and Blood Biomarker Collection
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Dec 2022to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
Nicole Simone, MD, 215-955-6702, Nicole.Simone@jefferson.edu
About this study
Official title: EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
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.
Read the detailed description
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.
- Conditions
- Breast Cancer, Ductal Carcinoma In Situ
- Being tested
- Survey Assessments, Diet Recall, Blood Biomarker Collection
- Keywords
- Social Determinants of Health, IL-6, cytokine profile, immune marker profile
- Medical subject headings
- Breast Neoplasms, Carcinoma, Intraductal, Noninfiltrating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AssessmentsOther
Also called 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
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 RecallOther
Also called Food Diary
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 CollectionOther
Also called Blood/Plasma Sample
The blood specimens will be processed for plasma and buffy coat.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Survey Assessments; Other: Diet Recall; Other: Blood Biomarker Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At Visit 1 (1 day)
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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+).
Measured: At Visit 1 (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start21 Dec 2022
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Thomas Jefferson UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicole Simone, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07478016
- Sponsor's protocol ID
- 22D.611
- Other IDs
- JT 20452
- Acronym
- EXIST
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 17 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT07478016
- Acronym / sponsor ID
- EXIST / 22D.611
- Conditions
- Breast Cancer, Ductal Carcinoma In Situ
- Keywords
- Social Determinants of Health, IL-6, cytokine profile, immune marker profile
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- 21 Dec 2022 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 17 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EXIST Cohort | – | Other: Survey Assessments, Other: Diet Recall, Other: Blood Biomarker CollectionWomen 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
Key exclusion criteria (3 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AssessmentsAlso: Centers for Medicare and Medicaid Services (CMS) survey, CMS Survey, NCCN Distress Thermometer and Problem List, National Comprehensive Cancer Network Distress Thermometer and Problem ListThe 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. | Other | EXIST Cohort |
| Diet RecallAlso: Food DiaryA 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 | Other | EXIST Cohort |
| Blood Biomarker CollectionAlso: Blood/Plasma SampleThe blood specimens will be processed for plasma and buffy coat. | Other | EXIST Cohort |
Primary outcome
Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation
Time frame: At Visit 1 (1 day)
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.
3 secondary outcomes
At-Risk Patients Identified for Illness-Related Psychosocial Complications
Time frame: At Visit 1 (1 day)
Cytokine Profiling
Time frame: At Visit 1 (1 day)
Immune Function
Time frame: At Visit 1 (1 day)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nicole Simone, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Ductal Carcinoma In Situ, run by Thomas Jefferson University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole Simone, MD (215-955-6702, Nicole.Simone@jefferson.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation (time frame: At Visit 1 (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2026.