Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

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

ARNA Breast

Andrey Tarabarov, MD

Egor Melnikov

Olga Puchkova, MD

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.

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

the absolute total number of matches between the results of the test system and histological confirmation of the diagnosis.

BIOMARKER-RU

ARNA Genomics US Inc.

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.

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

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.

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.

ARNA technology in general and the ARNA Breast test in particular are performed in a specialized laboratory. The courier service ships whole blood from the Clinic to the Laboratory. Thus, direct contact of the patient with the reagents does not occur, which increases the safety of the system. Plasma will be isolated from the sample in the Laboratory. Plasma is processed with a set of reagents, including inorganic and organic solutions and sets of specially synthesized biological components (oligonucleotides), for real-time polymerase chain reaction (RT-PCR) to determine the content of DNA fragments of selected oncological genes in a woman's blood plasma. The remaining plasma will be kept frozen for retests upon request. Samples will be not transferred to other countries.

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

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).

Primary Measured Values for Efficiency Assessment:

1. the absolute total number of matches between the results of the test system and mammography based on histological confirmation of the diagnosis;
2. 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;
3. 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.

Estimation of the area under ROC-curve (AUC)

Determination of a statistically significant relationship between test results and the age of patients at the time of testing

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

The ratio of true negative test results to the total number of negative test results

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer	NCT04927130	Breast Neoplasm...	ARNA Breast	35 Years - 65 Years	ARNA Genomics US Inc.
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer	NCT04890340	Breast Neoplasm...	ARNA Breast	35 Years - 65 Years	ARNA Genomics US Inc.
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer	NCT04890340	Breast Neoplasm...	ARNA Breast	35 Years - 65 Years	ARNA Genomics US Inc.
Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer	NCT04927130	Breast Neoplasm...	ARNA Breast	35 Years - 65 Years	ARNA Genomics US Inc.
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer	NCT04890340	Breast Neoplasm...	ARNA Breast	35 Years - 65 Years	ARNA Genomics US Inc.

Spots Global Cancer Trial Database for arna breast

Every month we try and update this database with for arna breast cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for arna breast

Every month we try and update this database with for arna breast cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for arna breast cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.