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

Locations (3)

FacilityCityStateZIPSite coordinators
Eastern Connecticut Hematology and OncologyNorwichConnecticut06360
Susan Johnson, MD
(860) 886-8362
Stephanie Pacheco
860-886-8362
Dennis Slater, MD (PRINCIPAL_INVESTIGATOR)
Cancer Center of Middle GeorgiaDublinGeorgia31021
Harsha Vyas, MD
(478) 272-8266
Audrey Bryan, BS
(478) 272-8266
Harsha Vyas, MD (PRINCIPAL_INVESTIGATOR)
Carolina Blood and Cancer Care AssociatesRock HillSouth Carolina29732
Sashi Naidu, MD
803-329-7772
Joseph DeSimone, BA
803-329-7772
Sashi Naidu, MD (PRINCIPAL_INVESTIGATOR)

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