In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer — ARNABreast  

Breast Neoplasms Clinical Trial

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 (Mammography/Ultrasound/MRI).

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 Sponsor's 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. ;

Related Conditions & MeSH terms

• Breast Neoplasms

• NCT number: NCT04890340
• Study type: Observational
• Source: ARNA Genomics US Inc.
• Contact: Andrey Tarabarov, MD
• Phone: +79161048621
• Email: at@arna.bio
• Status: Not yet recruiting
• Start date: May 21, 2021
• Completion date: December 31, 2021