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.
Part of paid clinical trials in Norwich, Connecticut.
- Sponsor
- Oxford Biodynamics Inc.
- Study ID
- NCT06635954
- Status
- Recruiting
Conditions
- Cancer
- Immune Checkpoint Therapy
- Immunotherapy
- PD-1
- PD-L1
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Study Details
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.
Key Dates
- Start date
- May 14, 2024
- Status verified
- Oct 2024
- Primary completion
- May 14, 2026
- Completion
- May 14, 2027
Study Design
- Enrollment
- 2,000 participants (estimated)
Primary Outcome Measure
Correlation between low probability of response prediction and actual response rate to Immune Checkpoint Inhibitor Therapy [ Time Frame: From enrollment to the final Episwitch test at week 24 ]
Central Contacts
- Ryan Mathis, MD888-200-3361
- Joseph DeSimone, BA803-329-7772
Locations (3)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Eastern Connecticut Hematology and Oncology | Norwich | Connecticut | 06360 | Dennis Slater, MD (PRINCIPAL_INVESTIGATOR) |
| Cancer Center of Middle Georgia | Dublin | Georgia | 31021 | Harsha Vyas, MD (PRINCIPAL_INVESTIGATOR) |
| Carolina Blood and Cancer Care Associates | Rock Hill | South Carolina | 29732 | Sashi Naidu, MD (PRINCIPAL_INVESTIGATOR) |
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