Status:
RECRUITING
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.
Lead Sponsor:
Oxford Biodynamics Inc.
Collaborating Sponsors:
Community Clinical Oncology Research Network, LLC
Conditions:
Cancer
Immunotherapy
Eligibility:
All Genders
18+ years
Brief Summary
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 inhibito...
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 Pro...
Eligibility Criteria
Inclusion Criteria:
- 18 years of age or older
- Stage III or IV cancer
- 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.
- ECOG performance status ≤ 2
- Clinically eligible for ICI therapy
- Able to read, understand and provide written informed consent.
- Willing and able to comply with the study requirements
Exclusion Criteria:
- Pregnant or breastfeeding
- History of bone marrow or organ transplant
- Contra indication for receiving Immune Check Point inhibitor.
Key Trial Info
Start Date :
May 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 14 2027
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT06635954
Start Date
May 14 2024
End Date
May 14 2027
Last Update
March 17 2025
Active Locations (3)
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1
Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States, 06360
2
Cancer Center of Middle Georgia
Dublin, Georgia, United States, 31021
3
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States, 29732