OctavaPink for Women With Dense Breast After Negative Mammography
OctavaPink® For Dense Breast After Negative Mammography
1 other identifier
observational
1,750
3 countries
7
Brief 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). 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2014
Typical duration for all trials
7 active sites
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
July 29, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedFirst Posted
Study publicly available on registry
August 5, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2017
CompletedAugust 19, 2014
August 1, 2014
1 year
July 29, 2014
August 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Positive MRI as an approval for a positive OctavaPink test
Approximately two month following a positive Octava test
Study Arms (2)
Positive OctavaPink
Following a positive OctavaPink result, an MRI is performed and any additional testing (required by the 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.
Interventions
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).
Eligibility Criteria
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).
You may qualify if:
- 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.
- Subjects with current biopsy/surgery proven breast cancer.
- 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.
You may not qualify if:
- 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.
- 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.
- Subjects with current mammography BIRADS assessment other than 1 or 2.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Detroit Clinical Research Center
Detroit, Michigan, 48201, United States
MD Anderson cancer center
Houston, Texas, 77030, United States
Shaarey Tzedek
Jerusalem, Israel
Shiba
Ramat Gan, Israel
Kaplan medical center
Rehovot, Israel
Sourasky medical center
Tel Aviv, Israel
Fondazione Carlo ferri
Rome, Italy
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: 24324350BACKGROUND
Biospecimen
Human plasma samples
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Edith Perez, Prof.
Mayo Clinic, Jacksonville Florida USA
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2014
First Posted
August 5, 2014
Study Start
August 1, 2014
Primary Completion
August 1, 2015
Study Completion
August 1, 2017
Last Updated
August 19, 2014
Record last verified: 2014-08