Clinical trial NCT02066025: Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
Official title: Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Keywords: breast cancer
cancer associated auto antibodies
breast cancer blood test
Lead sponsor: Eventus Diagnostics Ltd
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 1425
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The target population will be any women with a mammography result (positive or negative).

Women with negative mammography will be tested with the OctavaPink version to provide additional information to the doctors following a negative mammography.

Women with a positive mammography will be tested with OctavaBlue version to provide additional information to a physician.

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%.

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

Primary outcomes:
measure: Number of participants in each of the clinicaly defined groups (0,1 and 2).
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: "Carmel" Medical Center
Study officials:
affiliation: Eventus Dx
name: Galit Yahalom, Ph.D
role: STUDY_DIRECTOR
References:
citation: Yahalom G, Weiss D, Novikov I, Bevers TB, Radvanyi LG, Liu M, Piura B, Iacobelli S, Sandri MT, Cassano E, Allweis TM, Bitterman A, Engelman P, Vence LM, Rosenberg MM. An Antibody-based Blood Test Utilizing a Panel of Biomarkers as a New Method for Improved Breast Cancer Diagnosis. Biomark Cancer. 2013 Nov 19;5:71-80. doi: 10.4137/BIC.S13236. eCollection 2013.