Retrospective Comparative in Vitro Case-controlled Study... | NCT04927130

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

NCT04927130

Sponsor

ARNA Genomics US Inc.

Status

Unknown status

Last Update Posted

Jun 25, 2021Actual

Enrollment

150Estimated

Phase

Not provided

Conditions

Breast Neoplasm Female

Interventions

ARNA Breast

Countries

Russia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2021Actual

Primary Completion Date

Oct 29, 2021Estimated

Completion Date

Dec 31, 2021Estimated

First Submitted Date

Jun 9, 2021

First Submission Date that Met QC Criteria

Jun 9, 2021

First Posted Date

Jun 15, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2021

Last Update Posted Date

Jun 25, 2021Actual

Name	Class
BIOMARKER-RU	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Women in age 35 to 65 with confirmed breast cancer			Diagnostic Test: ARNA Breast
Healthy Volunteers			Diagnostic Test: ARNA Breast

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ARNA Breast	Diagnostic Test	A specific DNA fragments and globulins will be detected in blood plasma.	Healthy Volunteers Women in age 35 to 65 with confirmed breast cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	through study completion, an average of 1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

65 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Andrey Tarabarov, MD	Contact	+79161048621		at@arna.bio
Egor Melnikov	Contact	+79255022196		em@arna.bio