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EXploring Inflammation and Social deTerminants Study in Breast Cancer Patients

EXploring Inflammation and Social deTerminants (EXIST) Study in Breast Cancer Patients

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The patients will fill out questionnaires and provide a plasma sample."
  • "PRIMARY: Patients with newly diagnosed, biopsy proven breast cancer will be screened for SDoH and distress via a distress screen and for biomarkers."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This small study looks at how inflammation is linked to social and living conditions in women with breast cancer who have not started treatment. Participants take part once, answer questions, and give a sample of plasma, the liquid part of blood.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Female and older than 18 when agreeing to join.
  • A biopsy (tissue test) shows breast cancer that has spread into nearby breast tissue, or cancer still inside the milk ducts (DCIS).
  • Have not received treatment for this breast cancer.
  • Able to do all or most daily activities (ECOG score below 2).
  • Able to give consent to join the study.
  • Speak English.

Who can't join

  • Have started cancer treatment or already had surgery to remove the breast cancer.
  • Had another cancer within the past 6 months, except for non-melanoma skin cancer.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

PA