Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2026-01-02 @ 6:59 AM
Study NCT ID:
NCT04021069
Status:
UNKNOWN
Last Update Posted:
2019-07-16
First Post:
2019-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Sponsor:
Sunnybrook Health Sciences Centre
Organization:
Study Overview
Official Title:
Using Clinicopathomic Markers to Predict Neoadjuvant Chemotherapy Response in Breast Cancer
Status:
UNKNOWN
Status Verified Date:
2019-07
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
This study examines retrospective clinical data on patients diagnosed with breast cancer and monitor their response to neoadjuvant chemotherapy, incidence of locoregional recurrence, distant metastasis, and disease-free survival. The hypothesis of this study is that breast cancer patients who achieve a pathological complete response (pCR) to neoadjuvant chemotherapy demonstrate distinct clinicopathomic biomarker signatures.
Detailed Description:
The specific aims of the study are to (1) to identify clinicopathomic biomarkers from pre-treatment core biopsies that are predictive of response to neoadjuvant chemotherapy, (2) determine patterns of metastasis from primary breast cancer to other distant sites, (3) determine the rates of local recurrence in breast cancer patients, and (4) to determine if there are significant radiomic, pathomic, and clinical markers for recurrence and distant metastasis.
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?: