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

NCT04927130 | Unknown

• 1 other identifier: AB PoC 2021 RUS
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Breast Neoplasm Female

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Women in age 35 to 65 with confirmed breast cancer

Diagnostic Test: ARNA Breast

Healthy Volunteers

Diagnostic Test: ARNA Breast

Interventions

ARNA Breast DIAGNOSTIC_TEST

A specific DNA fragments and globulins will be detected in blood plasma.

Healthy Volunteers; Women in age 35 to 65 with confirmed breast cancer

Eligibility Criteria

• Age: 35 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARNA Genomics US Inc.: lead
• BIOMARKER-RU: collaborator

Study Sites (1)

K+31

Moscow, Russia

RECRUITING

Central Study Contacts

Andrey Tarabarov, MD

CONTACT

+79161048621; at@arna.bio

Egor Melnikov

CONTACT

+79255022196; em@arna.bio

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 15, 2021
• Study Start: June 16, 2021
• Primary Completion: October 29, 2021
• Study Completion: December 31, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Locations

RU (1)