Ignite Creation Date:
2024-05-06 @ 4:10 PM
Last Modification Date:
2024-10-26 @ 2:05 PM
Study NCT ID:
NCT04890340
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2021-04-19
Brief Title:
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value in Women With Various Forms of Breast Cancer
Sponsor:
ARNA Genomics US Inc
Organization:
ARNA Genomics US Inc
Study Overview
Official Title:
An International Multicenter Blind Comparative Controlled in Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value in Women With Various Forms of Breast Cancer in Comparison With Other Early Diagnostic Methods MammographyUltrasoundMRI
Status:
UNKNOWN
Status Verified Date:
2021-04
Last Known Status:
NOT_YET_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:
ARNABreast
Brief Summary:
The Study Objective is to evaluate the diagnostic efficacy of the liquid biopsy system versus the gold standard mammography or MRI or Ultrasound diagnosis in patients with suspected breast cancer
Detailed Description:
Women of the required age group in case of suspicion of breast cancer are sent to clarify the diagnosis for mammography or ultrasound of the mammary glands or MRI Based on the results of these studies a biopsy is prescribed to make a final diagnosis Before a biopsy to diagnose the presence absence of breast cancer patients do the blood sampling one time The blood is processed in the Sponsors laboratory The test results are compared with the data obtained from the biopsy The evaluation of the effectiveness of the method will be determined on the basis of the obtained data on the sensitivity and specificity of the test in relation to the reference method
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?:
False
Is an FDA AA801 Violation?:
None