Breast Cancer
Conditions
Keywords
breast cancer, cancer associated auto antibodies, breast cancer blood test
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%.
Interventions
None listed
Sponsors
Eventus Diagnostics Ltd
Study design
Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of participants in each of the clinicaly defined groups (0,1 and 2). | 3 years |
Countries
Israel
Contacts
Primary ContactGalit Yahalom, Ph.D
Outcome results
None listed