Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06230185
Status:
RECRUITING
Last Update Posted:
2024-01-30
First Post:
2024-01-09
Brief Title:
ctDNA Based MRD Testing for NAC Monitoring in TNBC
Sponsor:
Personalis Inc
Organization:
Personalis Inc
Study Overview
Official Title:
Breast Cancer-MinimalMolecular Residual Disease Detection and Therapy Monitoring in Patients With Early Stage TNBC-Phase I B-STRONGER-I
Status:
RECRUITING
Status Verified Date:
2024-01
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:
B-STRONGER-I
Brief Summary:
A prospective multicenter observational study to evaluate the correlation of Molecular Residual Disease MRD detection using circulating tumor DNA guided test to pathological complete response pCR after neoadjuvant chemotherapy NAC in stage I-III triple negative breast cancer TNBC Results from this study aim to improve MRD detection and disease outcomes for future patients
Detailed Description:
NeXT Personal CTA Clinical Trial Assay is a patient-specific tumor-informed device which allows for detection of MRD from cfDNA By using next generation sequencing technology whole genome sequencing WGS is conducted from DNA derived from patient tumor and normal samples A tumor informed personalized panel is then constructed that uses only a selection of DNA targets from the WGS by applying bioinformatic filters The targeted personalized panel is then sequenced using NGS and DNA derived from cfDNA from plasma samples The data from the cfDNA NGS are then further analyzed using bioinformatics filters to report the MRD status
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 |
|---|---|---|---|
| B-STRONGER-I | OTHER | Personalis | None |