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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04890340
Recruitment Status : Not yet recruiting
First Posted : May 18, 2021
Last Update Posted : May 18, 2021
Sponsor:
Collaborator:
BIOMARKER-RU
Information provided by (Responsible Party):
ARNA Genomics US Inc.

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.

Condition or disease Intervention/treatment
Breast Neoplasms 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.

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: 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).
Estimated Study Start Date : May 21, 2021
Estimated Primary Completion Date : November 29, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of woman with positive ARNA Breast test confirmed by biopsy (Sensitivity) [ Time Frame: through study completion, an average of 1 year ]

    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.


Secondary Outcome Measures :
  1. Efficiency Evaluation [ Time Frame: through study completion, an average of 1 year ]
    Estimation of the area under ROC-curve (AUC)

  2. Relationship between test results and the age [ Time Frame: through study completion, an average of 1 year ]
    Determination of a statistically significant relationship between test results and the age of patients at the time of testing

  3. Positive predictive value [ Time Frame: through study completion, an average of 1 year ]
    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

  4. Negative predictive value [ Time Frame: through study completion, an average of 1 year ]
    The ratio of true negative test results to the total number of negative test results


Biospecimen Retention:   Samples With DNA
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.


Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04890340


Contacts
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Contact: Andrey Tarabarov, MD +79161048621 at@arna.bio
Contact: Egor Melnikov +79255022196 em@arna.bio

Sponsors and Collaborators
ARNA Genomics US Inc.
BIOMARKER-RU
Investigators
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Study Director: Andrey Tarabarov, MD BIOMARKER-RU
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Responsible Party: ARNA Genomics US Inc.
ClinicalTrials.gov Identifier: NCT04890340    
Other Study ID Numbers: ARNA Breast 2021
First Posted: May 18, 2021    Key Record Dates
Last Update Posted: May 18, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases