Ignite Creation Date:
2024-05-06 @ 2:51 PM
Last Modification Date:
2024-10-26 @ 1:38 PM
Study NCT ID:
NCT04447651
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-10-10
First Post:
2020-06-22
Brief Title:
Patient Response to Immunotherapy Using Spliceosome Mutational Markers PRISMM
Sponsor:
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
True
Target Duration:
3 Years
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
Blood samples will be collected to
Evaluate whether mutations detected in tumor tissue using various Clinical Laboratory Improvement Amendments CLIA-certified next-generation sequencing assays correlate with those found in plasma tumor DNA ptDNA
To evaluate changes in ptDNA from baseline to 3 months in patients with spliceosome mutations receiving immune checkpoint inhibitors ICI
To evaluate changes in circulating immune cells PBMCs from baseline to 3 months in patients with spliceosome mutations receiving ICI
Enrollment Count:
6
Enrollment Type:
ACTUAL
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Cohort |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 66157 |
Who Masked List: