EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Individuals must meet all the following inclusion criteria to be eligible to participate in the study:
- •>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
排除标准
- •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
研究组 & 干预措施
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
干预措施: Survey Assessments (Other)
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
干预措施: Diet Recall (Other)
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
干预措施: Blood Biomarker Collection (Other)
结局指标
主要结局
Correlation Between Breast Cancer Patients' Social Determinants of Health (SDoH) and Systematic Inflammation
时间窗: 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.
次要结局
- Immune Function(At Visit 1 (1 day))
- At-Risk Patients Identified for Illness-Related Psychosocial Complications(At Visit 1 (1 day))
- Cytokine Profiling(At Visit 1 (1 day))