Ignite Creation Date:
2025-12-25 @ 3:56 AM
Ignite Modification Date:
2025-12-26 @ 2:48 AM
Study NCT ID:
NCT06672302
Status:
RECRUITING
Last Update Posted:
2024-11-04
First Post:
2024-10-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective Study to Develop and Clinically Validate an in Vitro Diagnostic Medical Device That Uses Blood to Classify Patients At High Risk for Breast Cancer
Sponsor:
EXoPERT
Organization:
Study Overview
Official Title:
A Multi-center, Single Arm, Prospective Exploratory in Vitro Diagnostic Devices Clinical Performance Study to Evaluate of in Vitro Diagnostic Devices for Auxiliary Diagnosis That Classifies High-risk and Low Risk Patients with Breast Cancer by Analyzing Surface-enhanced Raman Spectroscopy (SERS) Profiles of Extracellular Vesicles (EVs) Extracted from Human Plasma Using Artificial Intelligence
Status:
RECRUITING
Status Verified Date:
2024-10
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:
EXoPERT has developed a liquid biopsy-based in vitro diagnostic medical device that can diagnose cancer through blood. The in vitro diagnostic medical device for this clinical performance trial is a test device that applies a technology that measures Raman spectroscopic signals of extracellular vesicles in the blood and classifies high-risk and low-risk patients for breast cancer through artificial intelligence analysis.
The test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.
The test device used in this clinical performance trial is expected to assist in the differential diagnosis of high-risk and low-risk breast cancer patients by developing a software algorithm for an in vitro diagnostic medical device for auxiliary diagnosis that classifies high-risk and low-risk breast cancer patients and confirming the clinical efficacy and safety of the device through this clinical performance trial.
Detailed Description:
According to the Korean Breast Cancer Society, when comparing the five-year survival rate of breast cancer patients by stage from 2001 to 2012, the survival rate is 98.3% for stage 0, 96.6% for stage 1, and 91.8% for stage 2, but the survival rate for stage 4 patients with systemic metastasis is 34%. Therefore, early detection and accurate diagnosis are very important for breast cancer treatment.
Currently, breast cancer is diagnosed through breast ultrasound and mammography. These imaging modalities are defined by the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) to define the specificity and various characteristics of the lesion. BI-RADS is divided into six categories: Category 1 is no abnormality, Category 2 is a definite benign tumor, Category 3 is a high likelihood of benign tumor (≤2% positive predictive value), Category 4 is a low likelihood of malignancy (≤2% positive predictive value), except for Category 0, which is an incomplete determination, Category 4 is a moderate suspicion of malignancy (2\< positive predictive value \<95%), Category 5 is a very high probability of malignancy (positive predictive value ≥95%), and Category 6 is a pathologically diagnosed malignancy.
In the Breast Imaging Reporting and Data System (BI-RADS), biopsy is not required in category 3 because the likelihood of malignancy is 2% or less, so a 6-month follow-up is recommended, and biopsy is recommended starting from category 4A, where the frequency of malignancy is 3 - 10%. However, the BI-RADS criteria have a significant number of false-positive results, which leads to an increase in unnecessary biopsies. The need for complementary diagnostic tests that can overcome the limitations of conventional imaging tests and compensate for unnecessary biopsies is being emphasized.
Currently, breast cancer is diagnosed through breast ultrasound and mammography. These imaging modalities are defined by the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) to define the specificity and various characteristics of the lesion. BI-RADS is divided into six categories: Category 1 is no abnormality, Category 2 is a definite benign tumor, Category 3 is a high likelihood of benign tumor (≤2% positive predictive value), Category 4 is a low likelihood of malignancy (≤2% positive predictive value), except for Category 0, which is an incomplete determination, Category 4 is a moderate suspicion of malignancy (2\< positive predictive value \<95%), Category 5 is a very high probability of malignancy (positive predictive value ≥95%), and Category 6 is a pathologically diagnosed malignancy.
In the Breast Imaging Reporting and Data System (BI-RADS), biopsy is not required in category 3 because the likelihood of malignancy is 2% or less, so a 6-month follow-up is recommended, and biopsy is recommended starting from category 4A, where the frequency of malignancy is 3 - 10%. However, the BI-RADS criteria have a significant number of false-positive results, which leads to an increase in unnecessary biopsies. The need for complementary diagnostic tests that can overcome the limitations of conventional imaging tests and compensate for unnecessary biopsies is being emphasized.
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?:
False
Is an FDA AA801 Violation?: