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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Neoplasm Female
• Intervention / Treatment: Diagnostic test: ARNA Breast

• Study Type: Observational
• Enrollment (Anticipated): 150

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

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Recruiting
    • K+31
    • Contact: Olga Puchkova, MD; Phone Number: +79032730217; Email: o.puchkova@k31.ru

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: Non-Probability Sample

Study Population

Women of the required age group, in case of breast cancer has been confirmed but not treated, are sent to donate blood samples.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteers	Diagnostic test: ARNA Breast; A specific DNA fragments and globulins will be detected in blood plasma.
Women in age 35 to 65 with confirmed breast cancer	Diagnostic test: ARNA Breast; A specific DNA fragments and globulins will be detected in blood plasma.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: ARNA Genomics US Inc.
• Collaborators: BIOMARKER-RU

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2021
• Primary Completion (Anticipated): October 29, 2021
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: June 9, 2021
• First Submitted That Met QC Criteria: June 9, 2021
• First Posted (Actual): June 15, 2021

Study Record Updates

• Last Update Posted (Actual): June 25, 2021
• Last Update Submitted That Met QC Criteria: June 24, 2021
• Last Verified: June 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: AB PoC 2021 RUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No