Breast Neoplasm Female
Conditions
Brief summary
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.
Interventions
DIAGNOSTIC_TESTARNA Breast
A specific DNA fragments and globulins will be detected in blood plasma.
Sponsors
BIOMARKER-RU
ARNA Genomics US Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of true positive cases | through study completion, an average of 1 year | the absolute total number of matches between the results of the test system and histological confirmation of the diagnosis. |
Countries
Russia
Contacts
Primary ContactAndrey Tarabarov, MD
Backup ContactEgor Melnikov
Outcome results
None listed