Breast CancerNCT02209389
OctavaPink for Women With Dense Breast After Negative Mammography
An observational study of Breast Cancer, run by Eventus Diagnostics Ltd at 7 sites in 3 countries.
Trial summary
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). Read more about this study
- Who is it for?
- Ages 30 to 79 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 1,750 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Aug 2014to Aug 2017
- How long will I take part?
- 2 Years
- 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 30 to 79 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population for all parts of the protocol includes women above 30, who have had a mammography in the past 5-18 months, for which the result was negative (BIRADS assessment category 1 or 2), and on which they were defined as having dense breast tissue (BIRADS composition/density 3 or 4).
Who may be able to join
- Subjects with dense breast tissue according to ACR criteria, (BIRADS composition/density 3 or 4), or with specific area of high density behind the nipple.
- Subject with current mammography BIRADS assessment category other than 3.
- Signed inform consent form.
- Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases
- Subjects with current biopsy/surgery proven breast cancer.
- Additional inclusion criteria for Part 1A controls, Part 1B controls • Subjects with current negative mammography (BIRADS assessment category 1 or 2).
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- Additional inclusion criteria for Part 2
- Subjects with current negative mammography (BIRADS assessment category 1 or 2). All will perform an additional 1 year (12-18 months) up mammography to verify negative results.
- Additional inclusion criteria for Part 3 • Enriched patient population - Subjects with current/recent (less than 12 months) negative mammography (BIRADS assessment category 1 or 2). Mammography evaluation can be performed after recruiting.
Who cannot join
- Previous or concurrent malignancies of any type except for basal cell carcinoma of the skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.
- Previous or current ADH, ALH, LCIS.
- 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.
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- Subject undergoing immunosuppressive treatments.
- Subject with current mammography BIRADS assessment category of 3.
- Pregnancy at time of recruitment.
- Doctor medical judgment that prohibits participation in the study.
- Participating in a parallel clinical study that involves drug treatment, or may influence the course of this clinical trial.
- Additional exclusion criteria for Part 3
- Subjects with current mammography BIRADS assessment other than 1 or 2.
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Israel4 sites
Shaarey Tzedek
Jerusalem
Strano, Prof., strano@szmc.org.il
Strano, Prof.
Shiba
Ramat Gan
Sklair, Dr., Miri.SklairLevy@sheba.health.gov.il
Sklair, Dr.
Kaplan medical center
Rehovot
Tanir Allweis, Dr., tanirallweis@gmail.com
Tanir Allweis, Dr.
Sourasky medical center
Tel Aviv
Orit Golan, Dr., oritgolan@gmail.com
Orit Golan, Dr.
United States2 sites
Detroit Clinical Research Center
Detroit, Michigan, 48201
Benjamin Taggart, B.S., 248-716-7009, benjamin.taggart@dcrc.us
MD Anderson cancer center
Houston, Texas, 77030
Bevers, Prof.
Italy1 site
Fondazione Carlo ferri
Rome
Iacobelli, Dr., daniela.iacobelli@alice.it
Iacobelli, Dr.
About this study
Official title: OctavaPink® For Dense Breast After Negative Mammography
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.
Read the detailed description
This is a multicenter, prospective study containing 3 parts:
Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows:
Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.
Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.
Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.
Objectives:
(i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same properties in the subset of cases with invasive cancer (IDC and ILC).
(ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.
Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a positive OctavaPink test result in the dense breast negative mammography population.
Objectives:
(i) To compare the yield of cancer detection via MRI/biopsy among women with a positive OctavaPink test versus a negative OctavaPink test result.
(ii) To estimate the proportion of patients who are positive for the test in the target population
Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with dense breasts and negative mammography.
Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and negative mammography that is broadly consistent with that found in the dense breast population (but not necessarily negative mammogram) in Parts 1A and 1B.
- Conditions
- Breast Cancer
- Being tested
- MRI
- 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.
MRIDevice
Also called Magnetic Resonance Imaging
For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results).
| Study group | Role | What they receive |
|---|---|---|
| Positive OctavaPink | Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI). Receives: Device: MRI | |
| Negative OctavaPink - control | For any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and recalled for an MRI and any additional testing (required by the MRI).
MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result. Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive MRI as an approval for a positive OctavaPink test
Measured: Approximately two month following a positive Octava test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2014 (estimated)
- Study startAug 2014
- Primary completionAug 2015 (estimated)
- Study completionAug 2017 (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
- 1,750 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Eventus Diagnostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Edith Perez, Prof., Principal investigator, Mayo Clinic, Jacksonville Florida USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02209389
- Sponsor's protocol ID
- OctavaPink for Dense Breast
- Status last verified
- Aug 2014
- First submitted
- 29 Jul 2014
- Last updated
- 19 Aug 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 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OctavaPink® For Dense Breast After Negative Mammography
- ClinicalTrials.gov ID
- NCT02209389
- Acronym / sponsor ID
- OctavaPink for Dense Breast
- Conditions
- Breast Cancer
- Keywords
- breast cancer, cancer associated auto antibodies, breast cancer blood test
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,750 participants (estimated)
- Lead sponsor
- Eventus Diagnostics LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2014
- Primary completion
- Aug 2015 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 5 Aug 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.
The OctavaPink test is indicated as an adjunct to mammography for breast cancer screening in asymptomatic women for whom screening or diagnostic mammography findings are normal or benign (BIRADS assessment category 1 or 2) and breast tissue is dense (BIRADS composition/density 3 or 4). The device is intended to increase breast cancer detection in the described patient population. Based upon the result of OctavaPink, the patient will be further evaluated by their physician.
Detailed description
This is a multicenter, prospective study containing 3 parts:
Part 1 consists of Part 1A (optimization/training) and Part 1B (evaluation/testing) as follows:
Part 1A will optimize the OctavaPink test for women with dense breast tissue, and will not affect the treatment of the participants. Part 1A is an internal part done by EventusDx and no statistical evaluation is needed.
Objectives: To optimize the OctavaPink test, with the target of ≥95% specificity and ≥70% sensitivity.
Part 1B will assess the properties of the OctavaPink test using cases and controls obtained via the same criteria as in Part 1A. The sensitivity and specificity of the OctavaPink test must be confirmed as sufficiently high in samples in which EventusDx is blind to case/control status before using the test to affect clinical management of patients.
Objectives:
(i) To obtain a sensitivity estimate ≥60% with 95% CI lower limit ≥50% in the whole group of cancer cases (DCIS, IDC and ILC); also to obtain a sensitivity estimate with the same properties in the subset of cases with invasive cancer (IDC and ILC).
(ii) To obtain a specificity estimate ≥90% in controls with 95% CI lower limit ≥85%.
Part 2 will examine the yield of cancer detection by MRI/biopsy among women who have a positive OctavaPink test result in the dense breast negative mammography population.
Objectives:
(i) To compare the yield of cancer detection via MRI/biopsy among women with a positive OctavaPink test versus a negative OctavaPink test result.
(ii) To estimate the proportion of patients who are positive for the test in the target population
Part 3 will assess sensitivity of OctavaPink test in an enriched population of women with dense breasts and negative mammography.
Objectives: To obtain an estimate of sensitivity in women with dense breast tissue and negative mammography that is broadly consistent with that found in the dense breast population (but not necessarily negative mammogram) in Parts 1A and 1B.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 2 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Positive OctavaPink | – | Device: MRIFollowing a positive OctavaPink result, an MRI is performed and any additional testing (required by the MRI). |
| Negative OctavaPink - control | – | Device: MRIFor any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and recalled for an MRI and any additional testing (required by the MRI). MRI won't be performed to all negative OctavaPink results. Only one negative control will be assigned to each OctavaPink positive result. |
Who may qualify
- Ages
- 30 to 79 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population for all parts of the protocol includes women above 30, who have had a mammography in the past 5-18 months, for which the result was negative (BIRADS assessment category 1 or 2), and on which they were defined as having dense breast tissue (BIRADS composition/density 3 or 4).
Key inclusion criteria (9 listed)
- Subjects with dense breast tissue according to ACR criteria, (BIRADS composition/density 3 or 4), or with specific area of high density behind the nipple.
- Subject with current mammography BIRADS assessment category other than 3.
- Signed inform consent form.
- Additional inclusion criteria for Part 1A and Part 1B cases and Part 3 cases
- Subjects with current biopsy/surgery proven breast cancer.
Key exclusion criteria (13 listed)
- Previous or concurrent malignancies of any type except for basal cell carcinoma of the skin, squamous-cell carcinoma of the skin or cervical carcinoma in situ.
- Previous or current ADH, ALH, LCIS.
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIAlso: Magnetic Resonance ImagingFor any sample that is identified with a positive OctavaPink result, a negative sample from the same center, as close in time as possible, and of the same age decade, will be identified and will be recalled for an MRI and any additional testing if requested by doctor's (according to MRI's results). | Device | Negative OctavaPink - control, Positive OctavaPink |
Primary outcome
Positive MRI as an approval for a positive OctavaPink test
Time frame: Approximately two month following a positive Octava test
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2014.
- Background: 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.
Edith Perez, Prof. principal investigator
Mayo Clinic, Jacksonville Florida USA
7 sites in 3 countries: 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 7 sites in 3 countries.
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 9 inclusion and 13 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 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Israel, United States, Italy. 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, PhD. (+97226738854, galit@eventusdx.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Positive MRI as an approval for a positive OctavaPink test (time frame: Approximately two month following a positive Octava test). 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 NCT02209389, 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 Aug 2014.