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

Eventus Diagnostics

Status: Unknown

Conditions: Breast Cancer

Study type: Observational

Funder types: Industry

Identifiers

NCT02066025

OctavaBreast_1

Details and patient eligibility

About

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.

Full 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%.

Enrollment: 1,425 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

1,425 participants in 3 patient groups

group_0

Description:

Women with negative mammography (BIRADS 1-2), as negative controls.

group_1

Description:

Women with positive biopsy for (ID, IL, DCIS) as patients.

group_2

Description:

Women with positive mammography (BIRADS 3-4-5-6), and a negative biopsy diagnosis for breast cancer (ID, IL, DCIS) will be enrolled as benign (ADH, ALH, LCIS, fibroadenoma, fibrocystic changes (including sclerosing adenosis), Benign papillaoma, normal breast) as benigns.