Breast NeoplasmsARNABreastNCT04890340
In Vitro Study of the Liquid Biopsy Test System of the Diagnostic Value, in Women With Various Forms of Breast Cancer
An observational study of Breast Neoplasms, run by ARNA Genomics US Inc..
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Neoplasms
- What is being tested?
- ARNA Breast
- How many people
- 500 participants
- Where
- No sites listed yet
- Study dates
- 21 May 2021to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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).
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.
Read the 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
- Being tested
- ARNA Breast
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARNA BreastDiagnostic 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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: ARNA Breast | |
| Healthy Volunteers | Healthy woman in age 35 to 65. Receives: Diagnostic Test: ARNA Breast |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of woman with positive ARNA Breast test confirmed by biopsy (Sensitivity)
Primary Measured Values for Efficiency Assessment:
- the absolute total number of matches between the results of the test system and mammography based on histological confirmation of the diagnosis;
- 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;
- 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.
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Efficiency Evaluation
Estimation of the area under ROC-curve (AUC)
Measured: through study completion, an average of 1 year
Relationship between test results and the age
Determination of a statistically significant relationship between test results and the age of patients at the time of testing
Measured: through study completion, an average of 1 year
Positive predictive value
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
Measured: through study completion, an average of 1 year
Negative predictive value
The ratio of true negative test results to the total number of negative test results
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start21 May 2021 (estimated)
- Primary completion29 Nov 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARNA Genomics US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BIOMARKER-RU
- Responsible party
- Sponsor
- Investigators
- Andrey Tarabarov, MD, Study director, BIOMARKER-RU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890340
- Sponsor's protocol ID
- ARNA Breast 2021
- Acronym
- ARNABreast
- Status last verified
- Apr 2021
- First submitted
- 19 Apr 2021
- Last updated
- 18 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04890340
- Acronym / sponsor ID
- ARNABreast / ARNA Breast 2021
- Conditions
- Breast Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- ARNA Genomics US Inc.Industry (pharma, biotech, devices)
- Collaborators
- BIOMARKER-RU
- Study start
- 21 May 2021 (estimated)
- Primary completion
- 29 Nov 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 18 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women in age 35 to 65 with suspected breast cancer | – | Diagnostic Test: ARNA BreastWomen 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. |
| Healthy Volunteers | – | Diagnostic Test: ARNA BreastHealthy woman in age 35 to 65. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ARNA BreastWomen 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 | Diagnostic test | Healthy Volunteers, Women in age 35 to 65 with suspected breast cancer |
Primary outcome
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.
4 secondary outcomes
Efficiency Evaluation
Time frame: through study completion, an average of 1 year
Relationship between test results and the age
Time frame: through study completion, an average of 1 year
Positive predictive value
Time frame: through study completion, an average of 1 year
Negative predictive value
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrey Tarabarov, MD study director
BIOMARKER-RU
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms, run by ARNA Genomics US Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 May 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Andrey Tarabarov, MD (+79161048621, at@arna.bio), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of woman with positive ARNA Breast test confirmed by biopsy (Sensitivity) (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2021.