Clinical trial NCT04890340: 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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Neoplasms
Lead sponsor: ARNA Genomics US Inc.
Sponsor class: INDUSTRY
Collaborators: name: BIOMARKER-RU
First posted: 2021-05-18
Enrollment: 500
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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 but before biopsy.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of woman with positive ARNA Breast test confirmed by biopsy (Sensitivity)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Efficiency Evaluation
timeFrame: through study completion, an average of 1 year
measure: Relationship between test results and the age
timeFrame: through study completion, an average of 1 year
measure: Positive predictive value
timeFrame: through study completion, an average of 1 year
measure: Negative predictive value
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
Study officials:
affiliation: BIOMARKER-RU
name: Andrey Tarabarov, MD
role: STUDY_DIRECTOR
References: