Breast Neoplasm FemaleNCT04927130
Retrospective Comparative in Vitro Case-controlled Study of the Liquid Biopsy Test System in Women With Breast Cancer
An observational study of Breast Neoplasm Female, run by ARNA Genomics US Inc. at 1 site in Russia.
Trial 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. 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 Neoplasm Female
- What is being tested?
- ARNA Breast
- How many people
- 150 participants
- Where
- 1 siteRussia
- Study dates
- 16 Jun 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 breast cancer has been confirmed but not treated, are sent to donate blood samples.
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 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.
Who cannot join
- 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.
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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
1 site in 1 country.
Russia1 site, 1 recruiting
- Recruiting
K+31
Moscow
Olga Puchkova, MD, +79032730217, o.puchkova@k31.ru
About this study
Official title: 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
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
- Being tested
- ARNA Breast
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ARNA BreastDiagnostic test
A specific DNA fragments and globulins will be detected in blood plasma.
| Study group | Role | What they receive |
|---|---|---|
| Women in age 35 to 65 with confirmed breast cancer | Not described Receives: Diagnostic Test: ARNA Breast | |
| Healthy Volunteers | Not described Receives: Diagnostic Test: ARNA Breast |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted15 Jun 2021
- Study start16 Jun 2021
- Primary completion29 Oct 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 Neoplasm FemaleStudies 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
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ARNA Genomics US Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BIOMARKER-RU
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04927130
- Sponsor's protocol ID
- AB PoC 2021 RUS
- Status last verified
- Jun 2021
- First submitted
- 9 Jun 2021
- Last updated
- 25 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04927130
- Acronym / sponsor ID
- AB PoC 2021 RUS
- Conditions
- Breast Neoplasm Female
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- ARNA Genomics US Inc.Industry (pharma, biotech, devices)
- Collaborators
- BIOMARKER-RU
- Study start
- 16 Jun 2021 (actual)
- Primary completion
- 29 Oct 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 15 Jun 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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Women in age 35 to 65 with confirmed breast cancer | – | Diagnostic Test: ARNA Breast |
| Healthy Volunteers | – | Diagnostic Test: ARNA Breast |
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 breast cancer has been confirmed but not treated, are sent to donate blood samples.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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.
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 BreastA specific DNA fragments and globulins will be detected in blood plasma. | Diagnostic test | Healthy Volunteers, Women in age 35 to 65 with confirmed breast cancer |
Primary outcome
The number of true positive cases
Time frame: through study completion, an average of 1 year
the absolute total number of matches between the results of the test system and histological confirmation of the diagnosis.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm Female, run by ARNA Genomics US Inc. at 1 site in Russia.
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 4 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 25 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The number of true positive cases (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 25 Jun 2021.