Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT06966050
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.
Study:
NCT06966050
Study Brief:
Protocol Section:
NCT06966050