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

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: NCT04927130
Recruitment Status : Recruiting
First Posted : June 15, 2021
Last Update Posted : June 25, 2021
Sponsor:
Collaborator:
BIOMARKER-RU
Information provided by (Responsible Party):
ARNA Genomics US Inc.

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.

Condition or disease Intervention/treatment
Breast Neoplasm Female Diagnostic Test: ARNA Breast

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Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case-Control
Time Perspective: Retrospective
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
Actual Study Start Date : June 16, 2021
Estimated Primary Completion Date : October 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 confirmed breast cancer Diagnostic Test: ARNA Breast
A specific DNA fragments and globulins will be detected in blood plasma.

Healthy Volunteers Diagnostic Test: ARNA Breast
A specific DNA fragments and globulins will be detected in blood plasma.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

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): NCT04927130


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

Locations
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Russian Federation
K+31 Recruiting
Moscow, Russian Federation
Contact: Olga Puchkova, MD    +79032730217    o.puchkova@k31.ru   
Sponsors and Collaborators
ARNA Genomics US Inc.
BIOMARKER-RU
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Responsible Party: ARNA Genomics US Inc.
ClinicalTrials.gov Identifier: NCT04927130    
Other Study ID Numbers: AB PoC 2021 RUS
First Posted: June 15, 2021    Key Record Dates
Last Update Posted: June 25, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases