Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer

Study Overview
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Brief Summary
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Proof of Concept retrospective study. Women who have the diagnosis Breast Cancer ( confirmed by biopsy) will donate a blood samples. Tubes with blood will be transferred to the Sponsors Laboratory and ARNA Breast Test will be performed. The result of test will be compared with the biopsy result for each person.

Official Title
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An International Multicenter Blind Retrospective Comparative in Vitro Case-controlled Study of the ARNA Breast Liquid Biopsy Test System in Women With Biopsy Confirmed Breast Cancer

Conditions
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Breast Neoplasm Female

Intervention / Treatment
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* Diagnostic Test: ARNA Breast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Availability of signed and dated informed consent. Women from 35 to 65 years old, who are generally healthy, with confirmed breast cancer. Or without any neoplasms in breast (control group) Presence of a documented biopsy Presence of mammography, ultrasound or MRI of the mammary glands no later than three months. Exclusion Criteria: Pregnancy. Any other cancers diagnosed now or previously, with the exception of breast cancer. Therapy with cytostatic during the last three months. Chemotherapy within the past three months. Therapy with hormonal drugs, including all forms of contraceptive drugs. Therapy with other prohibited groups of drugs. Systolic blood pressure > 180 mm Hg. and / or diastolic blood pressure > 120 mm Hg. with repeated measurements. Simultaneous participation in another clinical study. Relative affiliation to the clinic, for example, the patient is a close relative of the researcher or a dependent person (for example, a clinic employee or student or a sponsor employee). A clinically significant condition or laboratory result that, in the opinion of the investigator, threatens the safety of the test subject, may interfere with assessments, or prevent the completion of the study. Failure to cooperate to participate in planned procedures, including the following examples: lack of understanding of language, mental illness, inability to visit the clinic. Diseases or conditions that may affect the conduct of the study or the interpretation of the results. History of organ transplantation. Blood transfusions within the last 6 months.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Women in age 35 to 65 with confirmed breast cancer<br> | Diagnostic Test: ARNA Breast<br>* A specific DNA fragments and globulins will be detected in blood plasma.<br>|
| Healthy Volunteers<br> | Diagnostic Test: ARNA Breast<br>* A specific DNA fragments and globulins will be detected in blood plasma.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of true positive cases | the absolute total number of matches between the results of the test system and histological confirmation of the diagnosis. | through study completion, an average of 1 year |