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.
Purpose
The purpose of this research is to test whether a blood-based 3D genome conformation mapping test called the Episwitch CiRT® can help to identify likelihood of response to PD-(L)-1 checkpoint inhibitors (a class of cancer drugs) across multiple oncological indications by comparing the results to actual treatment responses for cancer patients.
Conditions
- Cancer
- Immunotherapy
- PD-1
- PD-L1
- Immune Checkpoint Therapy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 18 years of age or older 2. Stage III or IV cancer 3. Selected by their healthcare provider to receive the Episwitch CiRT® test according to the current evidence-based schedule (per protocol) as part of their standard of practice. 4. ECOG performance status ≤ 2 5. Clinically eligible for ICI therapy 6. Able to read, understand and provide written informed consent. 7. Willing and able to comply with the study requirements
Exclusion Criteria
- Pregnant or breastfeeding 2. History of bone marrow or organ transplant 3. Contra indication for receiving Immune Check Point inhibitor.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Recruiting Locations
Norwich, Connecticut 06360
Dublin, Georgia 31021
Rock Hill, South Carolina 29732
More Details
- Status
- Recruiting
- Sponsor
- Oxford Biodynamics Inc.
Detailed Description
The Episwitch CiRT® (Checkpoint inhibitor Response Test) predicts how a patient will respond to immune checkpoint inhibitor (ICI) therapies by delivering a binary response likelihood profile (High Probability vs. Low Probability). Patients who have been diagnosed with stage III and IV cancer and who are candidates and/or planned to receive immune check point inhibitors as a therapy now or in near future will be offered the Episwitch CiRT™ before starting treatment or if on active treatment. Those patients with high probability of response to ICI will undergo repeat testing every three months. Patients will be followed for up to six months. Treatment administered, disease-free survival, overall survival, stable disease, progressive disease, complete response, time to recurrence, physician questionnaires and patient-reported outcomes will be recorded for six months. Comprehensive data of Social Determinants of Health (SDoH) will be collected to identify any correlation to unmet Health Related Social Needs (HrSN) and likelihood to response and/or resistance