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

Study Overview
=================
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 For the OctavaPink - 95% specificity and 50% sensitivity. For the OctavaBlue - 50% specificity and 95% sensitivity. The study will be considered as successful in any of the below options - If the new antigens incorporated in the OctavaPink chip will maintain specificity of at least 95% and increase the sensitivity to at least 85%. If the new antigens incorporated in the OctavaBlue chip will maintain sensitivity of at least 95% and increase the specificity to at least 85%.

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

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| group_0<br>Women with negative mammography (BIRADS 1-2), as negative controls. | |
| group_1<br>Women with positive biopsy for (ID, IL, DCIS) as patients. | |
| group_2<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants in each of the clinicaly defined groups (0,1 and 2). |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer blood test, breast cancer, cancer associated auto antibodies