Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-29 @ 10:57 AM
Study NCT ID:
NCT06966050
Status:
RECRUITING
Last Update Posted:
2025-11-06
First Post:
2025-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center MRD Registry for Inflammatory Breast Cancer
Sponsor:
M.D. Anderson Cancer Center
Organization:
Study Overview
Official Title:
Multi-center MRD Registry for Inflammatory Breast Cancer
Status:
RECRUITING
Status Verified Date:
2025-11
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 collect data from participants with IBC who may have had MRD testing and may have surgery in the future.
Detailed Description:
Primary Objectives
-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).
Secondary Objectives
* To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants.
* To evaluate the association of pre-surgery MRD to pathologic response.
* To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results
* To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally
* To determine the median lead time between the first MRD-positive result and clinical recurrence.
* To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.
-To determine the incidence of protocol specified pre-surgery MRD-positivity in IBC (assessment between completion of planned systemic therapy and surgery).
Secondary Objectives
* To establish the feasibility of multi-institutional MRD data collection using standard of care Signatera analysis in IBC participants.
* To evaluate the association of pre-surgery MRD to pathologic response.
* To evaluate participant reported QOL for worry about recurrence based in participants receiving MRD results
* To establish protocol-optional baseline and longitudinal MRD data collection in IBC participants and report the frequency of MRD longitudinally
* To determine the median lead time between the first MRD-positive result and clinical recurrence.
* To determine whether adjuvant therapies decrease the amount of MRD in participants, and the association with relapse.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCI-2025-03109 | OTHER | NCI-CTRP Clinical Registry | View |