Breast CancerNCT02066025
Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
An observational study of Breast Cancer, run by Eventus Diagnostics Ltd at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- How many people
- 1,425 participants
- Where
- 1 siteIsrael
- Study dates
- Mar 2014to Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Female subjects 18 years or over.
- Subjects following a mammography test.
- Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Israel1 site
"Carmel" Medical Center
Haifa, 34362
Arie Bitterman, MD, bitterman@clalit.org.il
Arie Bitterman, MD
About this study
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:
Read more
- 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.
Read the 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%.
- Conditions
- Breast Cancer
- Keywords
- breast cancer, cancer associated auto antibodies, breast cancer blood test
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants in each of the clinicaly defined groups (0,1 and 2).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2016 (estimated)
- Study completionMar 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 1,425 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eventus Diagnostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Galit Yahalom, Ph.D, Study director, Eventus Dx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02066025
- Sponsor's protocol ID
- OctavaBreast_1
- Status last verified
- Feb 2014
- First submitted
- 9 Feb 2014
- Last updated
- 19 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 24324350
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Test for Breast Cancer Associated Auto Antibodies - Improvement of Octava Blood Test
- ClinicalTrials.gov ID
- NCT02066025
- Acronym / sponsor ID
- OctavaBreast_1
- Conditions
- Breast Cancer
- Keywords
- breast cancer, cancer associated auto antibodies, breast cancer blood test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,425 participants (estimated)
- Lead sponsor
- Eventus Diagnostics LtdIndustry (pharma, biotech, devices)
- Study start
- Mar 2014
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2018 (estimated)
- First posted
- 19 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- Female subjects 18 years or over.
- Subjects following a mammography test.
- Subject with pathological evaluation after mammography with BIRADS 3-4-5-6.
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants in each of the clinicaly defined groups (0,1 and 2).
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2014.
- Results publication: PubMed 24324350Yahalom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Galit Yahalom, Ph.D study director
Eventus Dx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Eventus Diagnostics Ltd at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Galit Yahalom, Ph.D (+972546922422, galit@eventusdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants in each of the clinicaly defined groups (0,1 and 2). (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02066025, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Feb 2014.