Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test

• Conditions: Breast Cancer

• Registration Number: NCT02066025
• Lead Sponsor: Eventus Diagnostics Ltd

Brief Summary

Octava has two versions, each with a different intend of use.

OctavaPink is a qualitative in vitro diagnostic test service, performed by authorized clinical laboratories. The product is used for two following indications:

* Intend of Use #1: OctavaPink is indicated for women above 18 years old, who performed mammography and were determined negative for breast cancer. Being moderately sensitive (\>55% sensitivity) the test is able to detect 55% of mammography false negatives. In addition, being highly specific (\>95% specificity) it supplies additional evidence for true mammography negative result which will reduce examinees anxiety of being misdiagnosed as a result of high false negative mammography rate (10-30%)

* Intend of Use #2: OctavaPink is indicated for women above 18 years old, who performed biopsy after positive mammography and the biopsy result was negative. Being moderately sensitive (\>55% sensitivity) the test is able to detect 55% of biopsy false negatives. In addition being highly specific (\>95% specificity) it supplies an additional evidence for true biopsy negative result which reduces examinees anxiety of being misdiagnosed.

OctavBlue is a qualitative in vitro diagnostic test service, performed by EventusDx authorized laboratories. Intend of use of OctavBlue is the following:

• OctavBlue is indicated for women above 18 years old, who performed mammography and received doubtful results. Being highly sensitive (\>95% sensitivity) the test can help to reveal 95% of positive cases; and being moderately specific (\>55% specificity) - about half of negative cases. The test is not intended to be used as a standalone diagnostic technique but to supply additional information to a physician and help deciding about the further course of diagnosis.

Detailed Description

The primary objectives - To improve the specifications of the OctavaPink test and the OctavaBlue test. The current specifications being

1. For the OctavaPink - 95% specificity and 50% sensitivity.

2. For the OctavaBlue - 50% specificity and 95% sensitivity.

The study will be considered as successful in any of the below options -

1. If the new antigens incorporated in the OctavaPink chip will maintain specificity of at least 95% and increase the sensitivity to at least 85%.

2. If the new antigens incorporated in the OctavaBlue chip will maintain sensitivity of at least 95% and increase the specificity to at least 85%.

Study Timeline

• Status Verified: 2014-02
• Study First Submitted: 2014-02-09
• Study First Submitted QC: 2014-02-17
• Last Update Submitted: 2014-02-17
• Study First Posted: 2014-02-19
• Last Update Posted: 2014-02-19
• Study Start: 2014-03
• Primary Completion: 2016-03
• Study Completion: 2018-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1425

Inclusion Criteria

• Female subjects 18 years or over.
• Subjects following a mammography test.
• Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.

Exclusion Criteria

• Female Subjects less than 18 years of age
• Previous or concurrent malignancies
• Autoimmune disorders diagnosed subjects
• Hematological malignancies
• Subjects under active chemotherapy treatment or chemotherapy in the past 6 months
• Steroid treatment in the past 3 months
• Subject undergoing immunosuppressive treatments
• Subject with verified breast cancer other than invasive ductal or invasive lobular as verified by biopsy/cytology

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of participants in each of the clinicaly defined groups (0,1 and 2).	3 years

Trial Locations

Locations (1)

"Carmel" Medical Center; 🇮🇱 Haifa, Israel