In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer (ARNABreast)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Neoplasms
• Intervention / Treatment: Diagnostic test: ARNA Breast

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Andrey Tarabarov, MD; Phone Number: +79161048621; Email: at@arna.bio
• Study Contact Backup: Name: Egor Melnikov; Phone Number: +79255022196; Email: em@arna.bio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Women in age 35 to 65 with suspected breast cancer; Women in age 35 to 65 with suspected breast cancer, previously untreated. Additionally, eligible patients should have appropriate mammography results, either breast ultrasound or breast MRI.	Diagnostic test: ARNA Breast; 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
Healthy Volunteers; Healthy woman in age 35 to 65.	Diagnostic test: ARNA Breast; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency Evaluation	Estimation of the area under ROC-curve (AUC)	through study completion, an average of 1 year
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
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
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

Collaborators and Investigators

• Sponsor: ARNA Genomics US Inc.
• Collaborators: BIOMARKER-RU
• Investigators: Study Director: Andrey Tarabarov, MD, BIOMARKER-RU

Study record dates

Study Major Dates

• Study Start (Anticipated): May 21, 2021
• Primary Completion (Anticipated): November 29, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: April 19, 2021
• First Submitted That Met QC Criteria: May 12, 2021
• First Posted (Actual): May 18, 2021

Study Record Updates

• Last Update Posted (Actual): May 18, 2021
• Last Update Submitted That Met QC Criteria: May 12, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ARNA Breast 2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No