Spots Global Cancer Trial Database for In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer
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Trial Identification
Brief Title: In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer
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).
Study ID: NCT04890340
Conditions
Interventions
Study Description
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 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.
Keywords
Eligibility
Minimum Age: 35 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: Yes
Locations
Contact Details
Name: Andrey Tarabarov, MD
Affiliation: BIOMARKER-RU
Role: STUDY_DIRECTOR
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