Breast Cancer Clinical Trial
Official title:
Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
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.
Status | Not yet recruiting |
Enrollment | 1425 |
Est. completion date | March 2018 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Case Control, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Israel | "Carmel" Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Eventus Diagnostics Ltd |
Israel,
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 Improve — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of participants in each of the clinicaly defined groups (0,1 and 2). | 3 years | No |
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