Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-11 @ 2:09 AM
Study NCT ID:
NCT06479460
Status:
RECRUITING
Last Update Posted:
2024-07-24
First Post:
2024-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Application of ctDNA Dynamic Monitoring in Neoadjuvant Therapy for HER2-positive Breast Cancer Patients
Sponsor:
The First Affiliated Hospital with Nanjing Medical University
Organization:
Study Overview
Official Title:
Director, Department of Pathology, Jiangsu Provincial People's Hospital
Status:
RECRUITING
Status Verified Date:
2024-07
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:
1. To explore the predictive value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population;
2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.
2. To evaluate the prognostic value of ctDNA in HER2 positive breast cancer neoadjuvant therapy population.
Detailed Description:
This study plans to enroll 50 HER2 positive breast cancer patients in early stage (T2-3, N0-1, M0)/local late stage (T2-3, N2-3, M0 or T4a-c, Nany, M0), collect baseline tumor tissue samples of patients, as well as peripheral blood samples of multiple nodes at baseline, during new adjuvant therapy, after new adjuvant therapy (before surgery), and after surgery, detect the mutation of tumor tissue through 1021 panel, and conduct ctDNA detection of peripheral blood samples based on personalized panel design based on tumor tissue specific mutations, to explore the efficacy prediction and prognostic predictive value of ctDNA in HER2 positive new adjuvant therapy population.
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?: