Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06635954
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-05
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROWES
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 inhibitors a class of cancer drugs across multiple oncological indications by comparing the results to actual treatment responses for cancer patients
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 andor 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 andor resistance
Patients who have been diagnosed with stage III and IV cancer and who are candidates andor 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 andor resistance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None