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.
NCT ID: NCT06635954
Last Updated: 2025-03-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2000 participants
OBSERVATIONAL
2024-05-14
2027-05-14
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
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
2. History of bone marrow or organ transplant
3. Contra indication for receiving Immune Check Point inhibitor.
18 Years
ALL
No
Sponsors
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Community Clinical Oncology Research Network, LLC
UNKNOWN
Oxford Biodynamics Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Ryan Mathis, MD
Role: STUDY_DIRECTOR
Oxford BioDynamics
Locations
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Eastern Connecticut Hematology and Oncology
Norwich, Connecticut, United States
Cancer Center of Middle Georgia
Dublin, Georgia, United States
Carolina Blood and Cancer Care Associates
Rock Hill, South Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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What is CiRT?
Oxford Biodynamics
Community Clinical Oncology Research Network (CCORN)
Other Identifiers
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OB202401
Identifier Type: -
Identifier Source: org_study_id
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