Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06562777
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-15
Brief Title:
Observational Study of Sex Differences in Symptoms During Immune Checkpoint Inhibitor Treatment for People With Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
INvestigating Sex and Gender-Related Differences in Immunotherapy Treatment Effects INSITE
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This study aims to learn more about symptoms that patients experience while receiving immunotherapy for cancer
Detailed Description:
PRIMARY OBJECTIVES
I Characterize sex differences in patient-reported symptomatic immune-related adverse events
II Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender
OUTLINE This is an observational study
Patients complete surveys and have their medical records reviewed on study
I Characterize sex differences in patient-reported symptomatic immune-related adverse events
II Determine the level of discordance between clinician-assessed and patient-reported symptomatic immune-related adverse events according to patient gender
OUTLINE This is an observational study
Patients complete surveys and have their medical records reviewed on study
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