Breast Neoplasms Clinical Trial
— ARNABreastOfficial 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).
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.
Status | Not yet recruiting |
Enrollment | 500 |
Est. completion date | December 31, 2021 |
Est. primary completion date | November 29, 2021 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 35 Years to 65 Years |
Eligibility | Inclusion Criteria: - Availability of signed and dated informed consent. - Women from 35 to 65 years old, who are generally healthy, with suspected breast cancer. Or without suspicion of (control group) - Presence of a documented referral diagnosis of "breast cancer" - Presence of a documented biopsy referral - 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 cytostatics 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. |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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ARNA Genomics US Inc. | BIOMARKER-RU |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of woman with positive ARNA Breast test confirmed by biopsy (Sensitivity) | Primary Measured Values for Efficiency Assessment: the absolute total number of matches between the results of the test system and mammography based on histological confirmation of the diagnosis; the sensitivity of the test by groups, particularly: the ratio of the number of true-positive test results to the total number of patients in the group with the presence of a character; the specificity of the test by groups, particularly: the ratio of the number of true-negative test results to the total number of patients in the group with no character. A group of samples from patients with a confirmed diagnosis of breast cancer will be divided into 4 subgroups depending on the biological subtype of cancer identified on the basis of IHC analysis (luminal A, luminal B, HER2/neu, triple negative), also for the subgroups obtained the primary measured values will be calculated to identify these quantities based on the biological subtype of breast cancer. |
through study completion, an average of 1 year | |
Secondary | Efficiency Evaluation | Estimation of the area under ROC-curve (AUC) | through study completion, an average of 1 year | |
Secondary | Relationship between test results and the age | Determination of a statistically significant relationship between test results and the age of patients at the time of testing | through study completion, an average of 1 year | |
Secondary | Positive predictive value | The ratio of true-positive test results to the total number of positive test results h) the ratio of true negative test results to the total number of negative test results (negative predictive value) i) Positive and negative likelihood ratio | through study completion, an average of 1 year | |
Secondary | Negative predictive value | The ratio of true negative test results to the total number of negative test results | through study completion, an average of 1 year |
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