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

NCT ID: NCT04890340

Last Updated: 2021-05-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-05-21
• Study Completion Date: 2021-12-31

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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

ARNA Breast

Intervention Type: DIAGNOSTIC_TEST

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.

ARNA Breast

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

BIOMARKER-RU

UNKNOWN

Sponsor Role: collaborator

ARNA Genomics US Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andrey Tarabarov, MD

Role: STUDY_DIRECTOR

BIOMARKER-RU

Central Contacts

Andrey Tarabarov, MD

Role: CONTACT

at@arna.bio

+79161048621

Egor Melnikov

Role: CONTACT

em@arna.bio

+79255022196

Other Identifiers

ARNA Breast 2021

Identifier Type: -

Identifier Source: org_study_id