Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337097
Status:
RECRUITING
Last Update Posted:
2024-04-29
First Post:
2024-03-22
Brief Title:
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To learn if monitoring blood levels of heart injury troponin levels in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects
Detailed Description:
Primary Objectives
Myocarditis CTCAE version 50 grade 3
Ventricular tachycardia 30 seconds
Advanced atrioventricular block
Incident heart failure event
Cardiovascular mortality
Non-fatal sudden cardiac arrest
Acute coronary syndrome
Pericarditis
Pericardial tamponade
Secondary Objectives
Time from symptom onset to diagnosis of major adverse cardiovascular events
Time from symptom onset to diagnosis of myocarditis
Initial hospitalization duration for the adverse cardiovascular event from primary endpoint
Peak biomarker levels including troponin T troponin I creatine kinase and creatine kinase myocardial band
Percentage of patients with negative workup for myocarditis
Percentage of patients requiring major cardiac testing including echocardiograms cardiac magnetic resonance imaging andor invasive heart catheterization
Duration of interruption andor discontinuation of immune checkpoint inhibitor therapy
Cancer progression free survival
Time to next cancer therapy
Myocarditis CTCAE version 50 grade 3
Ventricular tachycardia 30 seconds
Advanced atrioventricular block
Incident heart failure event
Cardiovascular mortality
Non-fatal sudden cardiac arrest
Acute coronary syndrome
Pericarditis
Pericardial tamponade
Secondary Objectives
Time from symptom onset to diagnosis of major adverse cardiovascular events
Time from symptom onset to diagnosis of myocarditis
Initial hospitalization duration for the adverse cardiovascular event from primary endpoint
Peak biomarker levels including troponin T troponin I creatine kinase and creatine kinase myocardial band
Percentage of patients with negative workup for myocarditis
Percentage of patients requiring major cardiac testing including echocardiograms cardiac magnetic resonance imaging andor invasive heart catheterization
Duration of interruption andor discontinuation of immune checkpoint inhibitor therapy
Cancer progression free survival
Time to next cancer therapy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2024-02687 | OTHER | NCI-CTRP Clinical Registry | None |