Observational Study of Episwitch CiRT® for Immunotherapy Response
This study is looking at a blood test called Episwitch CiRT® to see if it can predict how well people with advanced cancer will respond to certain immunotherapy drugs, specifically PD-(L)-1 checkpoint inhibitors. These drugs help your own immune system fight cancer. The study will compare the test results to how patients actually respond to treatment. Researchers also want to see if this test could help save healthcare costs and if social factors (like where you live or your income) affect test results and patient outcomes. You might be able to join if you are 18 or older, have Stage III or IV cancer, and your doctor has decided you should receive the Episwitch CiRT® test as part of your care, or if you are eligible for immunotherapy. The study aims to enroll 2000 participants, but its current recruitment status is unclear.
- Study design
- This is an observational study involving 2000 participants. It is not a randomized trial, meaning participants are not assigned to different treatment groups by chance.
- What's involved
- You will have the Episwitch CiRT® test before starting or during immunotherapy. If your test shows a high chance of response, you will have repeat tests every three months. Your treatment, health status, and patient-reported outcomes will be recorded for up to six months.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to six months after enrollment.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.
At a glance
Conditions
Where it's being run
3 sites across 3 statesStudy leadership
- Ryan Mathis, MD · STUDY_DIRECTOR · Oxford BioDynamics
Who to contact
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What this trial measures
- Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor TherapyFrom enrollment to the final Episwitch test at week 24
At the time of enrollment, case report forms will be completed that capture the patient's current and previous treatments, stage of disease, and prognosis. After receiving results from Episwitch CiRT, a follow up case report form will be completed that captures the response prediction from the test as well as the patient's response to their current treatment, and whether or not that treatment is an ICI therapy. The patients on ICI that receive results that indicate low probability of response will be compared to their actual response to treatment.
- Establish Health Economics Outcomes Research based on the potential cost savings from foregoing ICI therapy based on Episwitch CiRT prediction of responseFrom time of enrollment to the 24-week follow up test results
Patients that are predicted to have a low probability of response to ICI therapy and are receiving ICI therapy will be identified throughout the study via case report forms. We will estimate drug cost savings based on the amount of ICI therapy received by the patient. We will also capture any immune related adverse events from the ICI therapy and account for any costs related to these reactions. This will all be used as a rough model and predictor of the potential cost savings of using the Episwitch CiRT in treatment decisions.
- Determine the existence of a correlation between Social Determinants of Health and test results and patient outcomesFrom time of enrollment to the 24-week follow up test results
Upon enrollment, patients will complete a Social Determinants of Health Questionnaire that captures the following information: ethnicity, race, quality of housing, housing insecurity, highest education, employment status, insurance, income, how frequently patients talk to those they care about, transportation needs, refugee status, and lack of access to the following resources food, utilities, phone, clothing, childcare, and medicine/health care. The responses will be used to identify patients that have no, low, or high needs and compare these groups' testing results and outcomes to each other. Further or more in-depth analysis may be needed to understand correlations between SDOH and ICI therapy outcome.