MedTrace Logo

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

NCT04890340 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 500

Last updated 2021-05-18

No results posted yet for this study

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.

Conditions

  • Breast Neoplasms

Interventions

DIAGNOSTIC_TEST

ARNA Breast

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

Sponsors & Collaborators

  • BIOMARKER-RU

    collaborator UNKNOWN

  • ARNA Genomics US Inc.

    lead INDUSTRY

Principal Investigators

  • Andrey Tarabarov, MD · BIOMARKER-RU

Eligibility

Min Age
35 Years
Max Age
65 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-05-21
Primary Completion
2021-11-29
Completion
2021-12-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04890340 on ClinicalTrials.gov