Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
1 other identifier
observational
1,425
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2018
CompletedFebruary 19, 2014
February 1, 2014
2 years
February 9, 2014
February 17, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of participants in each of the clinicaly defined groups (0,1 and 2).
3 years
Study Arms (3)
group_0
Women with negative mammography (BIRADS 1-2), as negative controls.
group_1
Women with positive biopsy for (ID, IL, DCIS) as patients.
group_2
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.
Eligibility Criteria
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.
You may qualify if:
- Female subjects 18 years or over.
- Subjects following a mammography test.
- Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
"Carmel" Medical Center
Haifa, 34362, Israel
Related Publications (1)
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.
PMID: 24324350RESULT
Biospecimen
Human plasma samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Galit Yahalom, Ph.D
Eventus Dx
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2014
First Posted
February 19, 2014
Study Start
March 1, 2014
Primary Completion
March 1, 2016
Study Completion
March 1, 2018
Last Updated
February 19, 2014
Record last verified: 2014-02