Clinical trial · Observational
EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients
EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
NCT07478016CI-TRIAL-00105738EXISTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ductal Carcinoma In Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood Biomarker Collection | Other | — | UNRESOLVED |
| Diet Recall | Other | — | UNRESOLVED |
| Survey Assessments | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- EXIST Cohort
- description
- 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
- interventionNames
- Other: Survey Assessments
- Other: Diet Recall
- Other: Blood Biomarker Collection
Primary outcomes (1)
- measure
- Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation
- timeFrame
- At Visit 1 (1 day)
- description
- 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.
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.