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:
Organization:
ARNA Genomics US Inc
Study Design
Study Type:
OBSERVATIONAL
Expanded Access Type Individual:
None
Expanded Access Type Intermediate:
None
Expanded Access Type Treatment:
None
Patient Registry:
False
Target Duration:
None
Design Allocation:
Design Intervention Model:
Design Intervention Model Description:
Design Masking Description:
Bio Spec Retention:
SAMPLES_WITH_DNA
Bio Spec Description:
ARNA technology in general and the ARNA Breast test in particular are performed in a specialized laboratory The courier service ships whole blood from the Clinic to the Laboratory Thus direct contact of the patient with the reagents does not occur which increases the safety of the system Plasma will be isolated from the sample in the Laboratory Plasma is processed with a set of reagents including inorganic and organic solutions and sets of specially synthesized biological components oligonucleotides for real-time polymerase chain reaction RT-PCR to determine the content of DNA fragments of selected oncological genes in a womans blood plasma The remaining plasma will be kept frozen for retests upon request Samples will be not transferred to other countries
Enrollment Count:
500
Enrollment Type:
ESTIMATED
Design Primary Purpose:
Design Masking:
Phases:
Observational Models:
| Name |
|---|
| Case-Control |
Time Perspective List:
Clinical Trial Statuses
| Name |
|---|
| 75659 |
Who Masked List: