Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2026-01-01 @ 11:58 AM
Study NCT ID:
NCT06595966
Status:
RECRUITING
Last Update Posted:
2024-09-19
First Post:
2024-09-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exploratory Research on Constructing a Computational Biological Model Based on NGS for MRD After Breast Cancer Surgery
Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Organization:
Study Overview
Official Title:
Exploratory Research on Constructing a Computational Biological Model Based on Next Generation Sequencing Technology for Monitoring Measurable Residual Disease (MRD) After Breast Cancer Surgery
Status:
RECRUITING
Status Verified Date:
2024-09
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:
This study will include 80 subjects after radical breast cancer resection, collect blood samples of the above subjects, observe and quantify the characteristic changes of cfDNA in the blood of breast cancer subjects after surgery, and establish a computational biological model based on next generation sequencing to monitor breast cancer MRD;
Detailed Description:
This study will include 80 subjects after radical breast cancer resection. The results of CA15-3, CEA, color Doppler ultrasound and other traditional postoperative monitoring examinations for breast cancer, as well as 5ml of peripheral venous blood, were collected on the day of enrollment/the 7th day after adjuvant treatment/the 3rd, 6th, 9th, 12th, 15th, 18th, 21st, 24th, 30th and 36th months after surgery. We observe and quantify the characteristic changes of cfDNA in the blood of breast cancer subjects after surgery, and establish a computational biological model based on next generation sequencing to monitor breast cancer MRD;
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?: